Data Management Unit, V3.1 University of Pennsylvania Treatment Research Center, 2010 Page 2

Transcription

1 Welcome to the Data Entry System User s Manual. This manual will cover all of the steps necessary for you to successfully navigate and operate the Data Management Unit s Web based data entry system. We ask that you please keep this manual readily available at all times when using the system so that in the event that a question arises you will be prepared. In the event that questions arise which are not addressed in this manual, we ask that you immediately contact the Data Management Unit, at either the or phone numbers listed in Appendix I of this manual. Table of Contents System Security and User Access. 2 System Requirements.. 2 Safeguards in the Event of System Failure.. 3 Passwords 3 Study Design 4 Accessing DMU Web Site and Data Entry System. 5 Selecting a Study. 7 Entering Study Header Information 8 Schedule.. 9 Data Collection (Researcher) 10 Form and Field Validation Submitting Data.. 13 Data Collection (Patient/Self Administered). 15 First Quality Assurance Check. 18 Logging Off the Data Entry System 20 Record Locking 22 Quality Assurance System 22 Updating.. 26 Overview of Printing. 26 Study Summary Reviewing From the Subject Progress Report.. 29 Reviewing From the Schedule. 30 Subject Summary Printable Report Administrative Menu.. 34 Special Instruments. 38 Visual Analog Scales Continuous forms.. 39 Appendix I Contact Information A-1 Appendix II Minimum System Requirements.. A-2 University of Pennsylvania Treatment Research Center, 2010 Page 1

2 In order to successfully and efficiently utilize the web based data entry system, a few key procedural issues must be addressed. Specifically; system security and user access, meeting minimum system requirements, safeguards in the event of system failure, passwords, and study design. System Security and User Access System security is maintained through the use of a double authentication system. What this means is that a system user is assigned two username/password combinations. The first is the one selected by the registered user and provides access to the main Data Management Web Site. Access to the web site is limited to authorized users by the following condition: All users must become registered with the Data Management Unit (DMU). To register for access to the web site please use the following URL: Access to the Data Management Unit s Web Site must be approved by the Director of DMU and the Senior IT Project Manager. The second username and password is assigned by the DMU, and provides access to the data entry portion of the web site. Strict standards are enforced when providing access to the data entry system. Users are only assigned to designated studies within the web entry system, and only the Study PI can authorize this assignment. The Study PI will validate users in writing for access and security assignment. If you do not have access to a specific study within the data entry system, and feel you should, please contact the Study PI. Additionally, all users of the Web data entry system must complete the Data Management Unit s training and certification. User Names and Passwords will only be assigned to certified individuals. Please contact DMU for the data entry training schedule. In order to maintain system security users must adhere to the procedures detailed in Logging off the Data Entry System (pg 20). The Data Management Unit will not be accountable for the improper use of any user account. In the event that your account becomes compromised please inform the DMU immediately. If the DMU notices unusual behavior associated with a user account, the account will be suspended and the user will be notified. System Requirements Minimum system requirements have been established by the Data Management Unit as an effective means of limiting technical problems associated with older incompatible systems. The DMU has spent a significant amount of time evaluating both PC and Macintosh based systems and browser technologies available for both. The minimum system requirements are based on these evaluations and are continually updated to include recent developments. (See Minimum System Requirements, Appendix II). The Data Management Unit cannot guarantee the stability or functionality of the entry system for those users attempting to access the system without meeting the minimum system requirements, nor can the DMU take responsibility for issues associated with a client s University of Pennsylvania Treatment Research Center, 2010 Page 2

3 system inability to access the data entry web site due to configuration or internet service provider issues. If requested the Data Management Unit will review and validate any system that is being prepared for use with the web data entry system. During the review process the Data Management Unit will assess system capabilities, as well as make recommendations on system improvements that may enhance ease of use and stability. Safeguards in the event of system failure The Data Management Unit strives to ensure that the entry system is fully operational, but realizes that system failures may occur. System failure procedures require that interviewers have paper copies of all instruments that are administered for a specific study. This procedure is required so that in the event of an un-recoverable system failure, the capturing of the data at an assessment point can occur. In the event that during the data entry process you encounter a system related error, that is, one that is program related, print out or document any messages that may appear and immediately contact the Data Management Unit (See Contact Information, Appendix I). If possible, attempt to correctly exit the system and discontinue use until the Data Management Unit has reviewed and contacted you with instructions. We ask that you follow these procedures to avoid any data loss. Data Management staff will attempt to recreate the steps leading up to the incident and correct any system related issues, as necessary. If the situation cannot be resolved in a reasonable amount of time, the assessment data will be collected on paper copies of the instruments for entry later into the web based system. A copy of all instruments can be obtained in the Study Library of the DMU Web Site. Find the study located within the study library, locate and click on the study name, from the study detail page, there is a link which says Forms Used in this Study, and this link will lead you to the page with the list of instruments currently used by the study you selected. Clicking on the name of any instrument will provide you details on that instrument, here you can find the downloadable pdf link, to download right click on the link, pick save target as, and you will be able to save the pdf to your computer and print them out. When contacting the DMU because of a system failure, in addition to documenting the error, please attempt to obtain the following information. Location Machine Type / Specifications Browser / Version Acrobat / Version Has System been modified? / Connectivity changed? Passwords The entry of your passwords via the double authentication system, described in System Security and User Access (pg 2), is considered to be the legally binding equivalent of your handwritten signature. This electronic signature is linked to every transaction you make within the entry system. Passwords are SOLELY for the individual users they are assigned to, and are not to be shared. Any user caught sharing his/her login information will have their supervisors alerted, and their accounts closed. We require strict security University of Pennsylvania Treatment Research Center, 2010 Page 3

4 procedures due to the sensitive nature of the data being collected, as well as for tracking and auditing purposes. DMU requests that you destroy your System Access Agreement after you have committed your password combination to memory. In the event you forget your username or password you will be required to contact DMU. We will contact you via telephone and, after validating who you are, we will provide you with the requested information. If you feel your password has been comprised, contact DMU and we will assign you a new password. Study Design The Data Management Unit requires a complete study review with investigators prior to the beginning of any new study. This is to avoid data capture and study design issues. All database and user interfaces are designed by using standardized instruments located in the Instrument Library of the DMU Web Site. The Instrument Library contains both a PDF copy of the standardized instruments, and a data dictionary outlining the database design. Newly created study specific instruments will have data dictionaries and appropriate user interfaces designed by DMU. Investigators will review study specific instruments before implementation. All the instruments used by the study are listed under the study itself. Most instruments will have field and form validation. Field validation checks for appropriate responses within a field (a question response). Form validation checks responses across two or more fields. This means in many cases interviewers will not be able to enter invalid data. Additionally, most fields require a field response, or cannot be left blank. Where appropriate an X may be entered if a subject refuses to respond to a question, or an N may be entered if the question is not applicable to the subject. All field and form validation will be outlined in the instruments data dictionary. During the study design period, please provide DMU with the specific requirements for field validations and form validations. Standardized databases and user interfaces will not be changed or customized for a specific study without the approval of the Instrument Review Committee. DMU has worked diligently to ensure that instruments are correct. If however, you believe you have found an error in an instrument or a field does not accept a response that you think it should, please contact DMU immediately. In the event that data required to be collected cannot be entered into a header screen, or an instrument is not obtainable within the Schedule we ask that the PI and the Data Management Unit be notified immediately so that the issue can be reviewed. (Study header screen and Schedule will be detailed later in this manual). The remaining sections of this manual are written in a step-by-step, easy to follow format. By following them you will be able to successfully complete the following: Access the Data Management Web Site Access the Data Entry Portion of the Data Management Web Site University of Pennsylvania Treatment Research Center, 2010 Page 4

5 Select the Correct Study Assignment Enter Study Header Information Collect Data Handle Exceptions, Form Validation, and Field Validation Submit Study Data Print Study Data Review Study Data Modify Study Data QA Study Data Exit the Data Entry System Contact the Data Management Unit Accessing DMU Web Site and Data Entry System To successfully access the data entry portion of the web site, you must first access the main Data Management web site. You cannot go directly to the data entry URL, as you will be redirected to the main web site to log in. To log into the main web site enter the following URL into your browser address bar: Figure 1 Next enter the usercode and password that you selected during the registration process (Figure 1). If you forgot your usercode or password, you can click on the link: Forgot your usercode or password (Figure 1), that will lead you to a page where you can enter your full name and submit a request for password retrieval. An will be sent to DMU requesting your login information, we will send the information back to you using the address you provided to us during your initial registration. University of Pennsylvania Treatment Research Center, 2010 Page 5

6 Once you have successfully entered your usercode and password, you will be redirected to the Homepage of the Data Management Unit web site (Figure 2). Figure 2 From here you will see the link titled Data Entry System. Clicking this will display another login dialog box (Figure 3). Figure 3 Enter the User Name and Password assigned to you from the Data Management Unit. DO NOT select the option to SAVE THIS PASSWORD IN YOUR PASSWORD LIST. Enabling this option could possibly allow unauthorized users to gain access to the Data Entry System. University of Pennsylvania Treatment Research Center, 2010 Page 6

7 Selecting a Study Once you have successfully entered your data entry username and password, you will be presented with a list of studies that you currently have access to (Figure 4). Figure 4 From this page you can select the study for which you would like to begin entering data, or you can select the link that will return you to the main web site. The Test Study link can be accessed to practice entering instruments as well as getting yourself familiar with our system. Please do not use the real study to practice, that will mix your testing data with the real data already collected. To select a study and begin the entry process, simply click on the study name (Figure 4). University of Pennsylvania Treatment Research Center, 2010 Page 7

8 Entering Study Header Information Once you have selected a study, you will be prompted with the study header screen (Figure 5 and 6). Figure 5 Figure 6 University of Pennsylvania Treatment Research Center, 2010 Page 8

9 The study header screen will have the name of the study at the top and the header fields highlighted in the section below the title. In this example from the DeFine study, you are required to enter the Subject ID, Session, and Time. Please note that most fields on the header screen are required, and cannot be skipped. Also note that each field is validated, and will be rejected if the data does not match the pre-defined field validations (See Study Design, page 4). The Go To QA Page link will lead you to our Quality Assurance System (See pg 22), Study Summary(See pg 27), Subject Summary(See pg 32), and Printable Report(See pg 33) links will be detailed later in this manual. Schedule After all header information has been entered for the current subject, you will be prompted with the schedule (Figure 7). The schedule displays a list of instruments to be collected for the particular assessment period. The instruments will be listed under categories representing the individuals whom are expected to administer them. For example, an instrument capturing vital signs would be listed under Nurse Practitioner or Doctor, and a self-administered instrument would be listed under Patient. The actual instrument name is used as a link to the instrument, simply clicking on the name will access the instrument. Figure 7 University of Pennsylvania Treatment Research Center, 2010 Page 9

10 The schedule of assessments also provides a means of tracking the current status of a subject. As you can see from Figure 7, the color legend tracks the progress of each instrument in the assessment period. If the background color is: WHITE, data has not been entered. GREEN, data has been entered. The instrument can still be edited through this link before QA1 is done (See Updating pg 26). After QA1, the instrument can only be reviewed through the instrument name link (See Reviewing From the Schedule pg 30). Please note that the instrument can still be modified in QA2 or Final QA. In this example, QA2 is checked before QA1 is done, that s because for this study, QA2 is not required, once you submit the data, QA2 will be automatically checked for you, so that you do not need to do QA2. RED WITH LINK, entry and QA have been completed and the data archived; the instrument cannot be modified. Please note that the instrument can still be reviewed through this link. RED W/O LINK, the instrument is marked as missing. (See Marked as missing pg 36). You will also note three boxes to the right of each assessment under the headings QA1, QA2, and Final QA. Each box represents a QA operation; once that QA operation has been performed a red check mark will appear. The QA process will be detailed later in this manual (See Quality Assurance System, pg 22). Data Collection (Researcher) To begin entering an instrument, simply click on the instrument name in the schedule (Figure 7). Instruments will be presented to you in Adobe Acrobat format (Figure 8); which is identical to the paper and pencil version with the exception of the data entry fields, and control buttons. University of Pennsylvania Treatment Research Center, 2010 Page 10

11 Figure 8 To begin entering the assessment, simply click within the field of the first question. Next type the response, then hit the tab key to move to the next question. Continue until you have completed the assessment. Form and Field Validation In the event that field validation is triggered, a dialog box will appear alerting you to the error. The dialog box will also provide you with the acceptable valid responses for that field (Figure 9). Figure 9 University of Pennsylvania Treatment Research Center, 2010 Page 11

12 To close the alert, simply click the OK button. You will be returned to the question on the instrument where the validation occurred. To continue simply enter a new value which meets the field validation requirements, then hit the tab key. You may also experience form validation (Figure 10). This differs from field validation in that the alert occurs because of values within two or more fields. To correct form validation errors you have the option of changing any values within the validation fields to produce a valid combination. Figure 10 To close the alert, simply click the OK button. To continue simply enter a new value in one (or both) of the fields which meets the form validation requirements. After correcting, hit the tab key to continue on with the instrument. Form validation may also be triggered when submitting data (See Submitting Data, pg 13). University of Pennsylvania Treatment Research Center, 2010 Page 12

13 Figure 11 This will be the case if you have attempted to submit data with a required field missing (Figure 11). To close the alert, simply click the OK button. To continue enter a response in the field that is missing. Submitting Data Once the instrument has been completely filled out, proceed to the bottom of the last page (Figure 12). Here you will notice a green button titled Submit Data. Clicking the Submit Data button will submit the data entered on the instrument to the Data Management database. The three other navigation buttons on this page perform the following: Figure 12 Reset Form - will clear all of the information entered, essentially starting over from scratch. Print Form - prints a copy of the instrument with the field responses. Return to Schedule - this button can be used if you have selected the wrong instrument and need to return to the schedule. Please note that if you click this button with information entered it will be lost. University of Pennsylvania Treatment Research Center, 2010 Page 13

14 Once you have submitted the data and the information has been successfully stored in the Data Management database, a confirmation screen will be displayed which will contain all of the relevant header information (Figure 13). Please review this information, as this will be the only indication as to whether data has been submitted successfully. Figure 13 From the confirmation screen you have three options. You can either fill out another form, you can QA the instrument that you just completed, or you can return to the header screen. Selecting Fill out another form from the confirmation screen will take you back to the schedule for the current client (Figure 14). From the schedule you can select the next instrument you wish to administer during the interview process. Selecting QA Now from the confirmation screen will lead you to the First QA check (See First Quality Assurance Check, pg 18). Return to header will lead you to the header page, here you can fill out the header for a different client or for the same client with different time periods. Figure 14 You will notice that as you complete each instrument it becomes highlighted in green on the schedule. University of Pennsylvania Treatment Research Center, 2010 Page 14

15 Data Collection (Patient/Self-Administered) To begin a patient instrument, the technician will be required to prepare the instrument for data entry. The technician must login to the Data Entry System, select the appropriate study, and enter the appropriate header information for that particular subject. Enter Patient forms continuously: For patient/self-administered instruments, you have the option of allowing the patient to enter the instruments continuously. This option can be added to any study upon request. Below are the details on how continuous patient form administration differs from normal patient form administration (See Figure 15). Figure 15 If the Enter Patient forms continuously checkbox is not checked, then the patient administered instruments will be entered exactly like the researcher administered instruments (see pg10). If the Enter Patient forms continuously checkbox is checked, then the patient administered instruments will be presented one by one once the header information has been collected and submitted. (See Figure 16). University of Pennsylvania Treatment Research Center, 2010 Page 15

16 Figure 16 Clicking on the instrument name, will be opening the instrument in Adobe Acrobat format, the same format as the researcher administered instruments, the only difference is the navigation buttons at the bottom of the page, only the Submit Data button is present. The Reset Form, Print Form and Return to Schedule buttons are not shown (Figure 17). Figure 17 University of Pennsylvania Treatment Research Center, 2010 Page 16

17 After clicking on the Submit Data button, the patient will be presented with a link to the next patient instrument to be administered (See Figure 18) Figure 18 The patient will need to enter the forms one by one until they have finished entering all the forms for the time period selected in the header. Once all of the patient forms have been administered, the patient will see a screen telling them they have finished entering all the patient forms (See figure 19). From here they can return to header page. Figure 19 University of Pennsylvania Treatment Research Center, 2010 Page 17

18 If the patient can not finish entering all the patient instruments for the time point selected, the technician can simply log off the system once the patient completes entry of any patient form (submits data). Prior to clicking the next instrument the technician simply closes the browser, the next time the patient comes in, the technician enters the patient s header information and checks the Enter Patient forms continuously checkbox, the patient will resume entry with a link to the instruments they did not finish at the prior session, one by one. To log off the system correctly see instructions at Logging off the Data Entry System at page 20. First Quality Assurance Check (QA1) Only the user that administered the instrument can perform the QA1 function; other users are prohibited from this function (unless the form is a continuous form in which case any user can perform the QA1 function). A user can perform QA1 by two means; either by performing the function immediately after data collection, or by entering the Quality Assurance system. The first method is described in this section. The second method is described in the Quality Assurance System section (See pg 22). When entering the QA system from the confirmation screen (Figure 13, pg 14) by clicking on QA now, a complete Adobe Acrobat version of the instrument you just submitted will be returned to you. Appended to the beginning of the instrument will be the complete header information (Figure 20). The instrument will also contain all the entered responses (Figure 21). Figure 20 Figure 21 In the QA system, navigation within the instrument is the same as data collection. Once you click on a field you can use the tab key to move forward. The user can modify any responses with the exception of the header information. Simply click on, or tab to, the field you wish to modify and enter a new response. All form and field validations will still be present as it was with data collection. Once you have finished checking the fields, proceed to the bottom of the instrument (Figure 22). University of Pennsylvania Treatment Research Center, 2010 Page 18

19 Clicking the QA-1 button will finalize the QA1 process and send the information to the Data Management database. Figure 22 The two other navigation buttons on this page perform the following: Print Form prints a copy of the instrument with field responses and header information. Return to Schedule will return you to the schedule without submitting any information. The original data collected will be maintained, but the QA1 process and any corrections will still need to be performed. Once you have completed the QA1 process and the information has been successfully stored in the Data Management database, a confirmation screen will be displayed (Figure 23). This confirmation screen will inform you of the completion of QA1 and will also contain a table of any fields that were modified during the QA1 process. Figure 23 This table will also be appended to the Adobe Acrobat version of the instrument. From the confirmation screen you have three options. You can fill out another form, go to the QA page, or return to header. University of Pennsylvania Treatment Research Center, 2010 Page 19

20 Selecting Fill out another form from the confirmation screen will take you back to the schedule for the current client (Figure 14, pg 14). From the schedule you can select the next instrument you wish to administer during the interview process. Selecting Go Back to QA page will return you to the Quality Assurance (QA) System; this is detailed in Quality Assurance System (See pg 22) of this manual. Selecting Return to Header will return you to the header page; you can enter data for a different client or the same client with a different time period. Logging off the Data Entry System Once you have completed operations within the Date Entry System, you are required to properly log off the system. It is very important that you log off the system properly so that your account is closed and not active. An account left open would be available for use by someone other than you. To log off, simply close your web browser application within any screen except an open instrument. For more information on operating systems and Internet browsers see the Minimum System Requirements, Appendix II For Internet Explorer (IE) PC users log off can be performed by clicking either the button in the upper right corner or the program icon at the left corner. You may also select the File, then Close option from the drop down menu (Figure 24). Figure 24: PC Internet Explorer (IE) University of Pennsylvania Treatment Research Center, 2010 Page 20

21 For Firefox PC users log off can be performed by clicking the button in the upper right corner. You may also select the File, then Exit option from the drop down menu (Figure 25). Figure 25: PC Firefox For Safari MAC users log off is performed by clicking the Safari, then Quite Safari option only (Figure 26). Clicking the in the upper left corner or the or buttons in the upper right corner on Macintosh systems do not close the browser application. Figure 26: MAC Safari University of Pennsylvania Treatment Research Center, 2010 Page 21

22 Record Locking As mentioned earlier you can close the browser application in any screen to logoff except an open instrument. If you close the browser within an instrument it will become inaccessible for approximately two hours, this is because all records are locked during the data entry process to insure data integrity. A record is a subject s instrument, within a time period. When you begin the data entry process the record is locked, when you complete the process the record is released, this prevents other users from accessing the record you are currently working with. If you close your browser during this process the record does not get released until a series of cleanup routines determine that the record has been abandoned. Figure 27 If you logged off incorrectly, or another user attempts to access a record currently in use, a Record Lock Error Screen will appear (Figure 27). Quality Assurance System The Quality Assurance System is a system of data checks that must be performed on a record. Individual users are assigned QA rights by the study investigator (See System Security and User Access, pg 2). The QA system has three components; First Quality Assurance Check (QA1), Second Quality Assurance Check (QA2), and Final Quality Assurance Check (Final QA). A record progresses within the QA system after each check is performed. Some studies only need two Quality Assurance checks (QA1 and FQA), some studies only need one Quality Assurance check (QA1 only or FQA only). QA1 is limited to the individual users that performed the original administration of the instrument with the exception of the continuous forms (See pg 39). QA1 will appear in the QA system only if the check was not performed within the Data Entry System (See First Quality Assurance Check, pg 18). University of Pennsylvania Treatment Research Center, 2010 Page 22

23 QA2 is an optional check, if designated by the Study Investigator during the design phase of a study. The individual that performed the original administration of the instrument cannot perform QA2. Another user, with the appropriate study rights, will be required to perform this data check. Final QA is a check performed by a Senior Level individual within the study, designated by the Study Investigator. When the Final QA is completed the record becomes archived, and is no longer accessible for modification. As described earlier in this manual, the QA system progress is tracked on the Schedule through a color legend and series of check marks. (See Schedule, Figure 7, page 9). The QA system can be entered by clicking on the link Return to QA page. You will be given the option of how you would like to have the records presented (Figure 28). Figure 28 QA page Select a grouping method and then click Submit. Grouping by Subject will give you a list of Subject Numbers. Grouping by Form and Sequence will give you a list of Forms sorted by the assessment periods. After selecting a grouping method you are presented with a list of QA operations that need to be performed (Figure 29). As stated earlier records must progress through each QA operation. In Figure 29, there are records that need QA1 and separate records that University of Pennsylvania Treatment Research Center, 2010 Page 23

24 need QA2. Final QA is not displayed because either; the user does not have rights to perform Final QA, or currently there are no records that have passed through QA2. Figure 29 Select the QA operation you want, and then click the Submit button. Depending on the grouping and the QA operation selected, you will receive a list of either subject numbers or forms that need to have the selected QA operation. When receiving a list by subject, selecting a subject number will produce a list of forms. Simply clicking the form name will start the selected QA operation. When receiving a list by form and sequence, selecting a form will produce a list of subject sorted by the assessment periods. Simply clicking on the subject number will start the selected QA operation. If you do not wish to perform a QA operation after viewing the list, the Go Back to QA Page link is an option that will return you to the QA page (Figure 28). Once you have selected either a subject number or a form name, the Adobe Acrobat version of the instrument is returned, and the QA system operates as described earlier in the First Quality Assurance Check (See pg 18). Appended to the beginning of all instruments will be the complete header information. You can navigate, and modify if need, as with QA1. All form and field validation will be present. Each time you complete the selected data check; you need to proceed to the bottom of the instrument (Figure 30). Clicking the QA button will finalize the selected QA operation and send the information to the Data Management database. The QA button title will change depending on the selected QA operation; QA-1, QA-2, or Final QA. University of Pennsylvania Treatment Research Center, 2010 Page 24

25 Figure 30 The two other navigation buttons on this page perform the following functions: Print Form prints a copy of the instrument with field responses, header information and appended changes. Return to QA List will return you to the subject list that needs to be QA-ed without submitting any information. The original data, and any pervious modifications will be maintained but the selected QA process and any corrections will still need to be performed. Once you have completed a QA operation and the information has been successfully stored in the Data Management database, a confirmation screen will be displayed (Figure 31). This confirmation screen will inform you of the completion of the QA operation and also contains a table of any fields that were changed during the QA process. This table will also be appended to the Adobe Acrobat version of the instrument. In Figure 31, the modification table shows that no information on the instrument was changed. Figure 31 From the confirmation screen you have three options. Pick another Form for this Subject to will continue the selected QA process with the same subject. (Note: this would be Pick another Subject for this form to if grouped by form). Pick another Subject to you can pick a different subject for the selected QA process. Go Back to QA Page will return the users to the QA Page (Figure 28). University of Pennsylvania Treatment Research Center, 2010 Page 25

26 You can log off the QA system at any time by following the same procedures outlined in Logging off the Data Entry System (See pg 20). The remainder of this document contains information related to the Data Entry System or special features of the system. Updating Updating is a process whereby the user that has collected the instrument can correct information before the QA process begins. Updating can only be performed by the user that collected the information with the exception of continuous forms (see pg 39). To update a record simply select the instrument from the Schedule, make any necessary corrections, then click the Update button on the bottom of the instrument. Overview of Printing Among the navigation buttons on the bottom of every Adobe Acrobat instrument will be the Print Form option. Throughout the manual you have seen reference to the Print Form button. When using the system you can print the instrument at any point during the entry process, but note that there are some key differences to the resulting print-out depending on what portion of the system you are in. Prior to submitting data to the Data Management database the print-out will only contain the instrument. All print-outs created after data has been submitted to the Data Management Unit will contain a header appended to the top containing all study specific identifier information (Figure 32). Figure 32 A Data Management Unit Number will be printed on every page of the instrument in the upper right hand corner. University of Pennsylvania Treatment Research Center, 2010 Page 26

27 Appended to the end of all instruments printed out after initial submission will be a modification table documenting any changes that have occurred to the instrument since the initial submission (Figure 33). Figure 33 Study Summary The study summary provides an easy to use; real-time table formatted view of the study progress. This information is presented in a drill down format allowing for a global view of study progress displaying overall client population progress. More detailed information regarding a particular subject s progress within an assessment period can also be obtained. To access the study summary simply click the link Study Summary from the header page (Figure 34). Figure 34 University of Pennsylvania Treatment Research Center, 2010 Page 27

28 Once you have clicked the link you will be taken to a screen that displays a formatted table (Figure 35). The first column contains the subject numbers. Figure 35 The first two rows are the assessment periods within the study, based on the study schedule. The intersection of the subject row with the assessment column provides a color-coded cell. These color codes provide information on the subject s status for that particular assessment period. The color-codes are: White: The subject has not begun the assessment period yet. Green: The subject has begun this assessment period, but has not completed all the instruments or the instruments still need to complete the QA process. Red: The subject has begun this assessment period, and has completed all the instruments. All instruments for this client and this assessment period have also completed the QA process. To obtain more detailed information about the subject s progress regarding this assessment period, simply click the subject s number within the cell. If there is no subject number within a cell, then the subject has not begun that assessment period yet. Once the subject s number has been clicked a new table will be displayed (Figure 36). University of Pennsylvania Treatment Research Center, 2010 Page 28

29 Figure 36 The first column contains the subject number The first row is the name of the instruments that are to be completed within the selected assessment period. The intersection of the subject row with the instrument column provides a color-coded cell. These color codes provide information on the subject s status for that particular instrument. The color-codes are: Gray with no number: The patient has not begun the instrument yet. Gray with number: The patient has begun the instrument but QA1 has not been done. Green: The patient has begun this instrument, but the instrument still needs to complete the QA process. Red with number: The patient has begun this instrument, and the instrument has completed the QA process. Red with no number: The instrument is marked as missing (see pg 36). Reviewing From the Subject Progress Report Reviewing is a process whereby; any user with access rights to the selected study can review a read-only copy of a collected instrument. Reviewing can be done at any time from within the Subject Progress Report. Simply click on the subject number within the cell of the instrument that you would like to review. A read-only copy of the Adobe Acrobat version of the instrument will be returned to you with the header information and the appended modification table (Figure 37). University of Pennsylvania Treatment Research Center, 2010 Page 29

30 Figure 37 Clicking Return to Subject Summary button will return you to the Subject Summary Page (Figure 36) for the current subject. Clicking Print Form button will print the instrument Reviewing From the Schedule Reviewing may also be done at any time from the Schedule (Figure 38), with the exception of a user who has administered an instrument but has not performed QA1 process. In this case, the system will automatically recognize the user and present that user with the updating option. You must be within the Data Entry System or the QA System to obtain a schedule. To access a schedule from outside the system you must select a study, and then have the header information, with the exception of the date field, for the record you wish to review (this information can easily be obtained from the Study Summary, See pg 27.) In the study header you can enter the current date, as this will not overwrite the original data. University of Pennsylvania Treatment Research Center, 2010 Page 30

31 Figure 38 From the Schedule, Simply click on the Instrument Name for the record you would like to review. A read-only copy of the Adobe Acrobat version of the instrument will be returned to you with the header information and the appended modification table (Figure 39). Figure 39 Clicking Return to Schedule button will return you to the schedule for the current subject. Clicking Print button will print the instrument with the data. University of Pennsylvania Treatment Research Center, 2010 Page 31

32 Subject Summary The subject summary provides detailed information about the overall assessment periods, which instruments have been administered, which instruments have not been administered, and which instruments have been marked as missing (see pg 36). To access the subject summary simply click the link Subject Summary from the header page. Clicking the link will lead you to a page where you can select the subject that you would like summary information for from a drop down list of current subjects within the system (Figure 40). After you have selected a subject from the drop-down list you will be led to a page with detailed information about the selected subject. (Figure 41) Figure 40 Figure 41 The first row is the assessment periods within the study, based on the study schedule. The first column contains all the instruments used in the study. University of Pennsylvania Treatment Research Center, 2010 Page 32

33 The intersection of the instrument row with the assessment period column provides a color-coded cell. These color codes provide information on the subject s status for that particular instrument at that assessment period. The color-codes are: Gray with N/A: The instrument is not needed for that assessment period. Green with Done: The instrument is administered for that assessment period. Red with Miss: The instrument has not been administered for that assessment period. Red with Marked As Miss: The instrument is marked as missing for that assessment period. Printable Report (List of Subjects and Forms that Final QA not done) When Final QA has been performed on a record the record becomes archived, no more changes can be made to that record. When you submit an online data request to have an extract of the data sent to you, we filter the data set to include only those records that have been final QA-ed. Before submitting an online data request, you may want to find out which records have not completed the final QA process. The way to find out this information is from the header page link titled Printable Report (List of Subjects and Forms that Final QA not done) (Figure 34). Clicking on this link will lead you to the following page (figure 42): Figure 42 University of Pennsylvania Treatment Research Center, 2010 Page 33

34 This page will display, grouped by subject # and time points, all assessments that have not been final QA-ed. It is recommended that all Final QA be performed in a timely manner so that data extractions contain as much completed data as possible. Administrative Menu The administrative menu option will appear on the header screen of a selected study for those users that have been assigned administrative rights (Figure 43). Figure 43 The administrative menu will provide you with a list of management features for the selected study (Figure 44). Figure 44 University of Pennsylvania Treatment Research Center, 2010 Page 34

35 One of those options is Un-Archive / Header Correction Requests (Figure 45). This option will allow you to either generate an requesting that a currently archived record (one in which QA1, QA2, and Final QA have been completed), be un-archived, or generate an requesting that header information for a particular instrument be corrected. Figure 45 Once presented with the screen you have two options, either Unlock Archived Record, or Correct Header Information. If you select Unlock Archived Record, you must enter the Subject Number/Identifier; select a form from the drop-down list, the original header value, and the reason why the record is being unlocked from archival. If you select to Correct Header Information, you must enter the Subject Number/Identifier, select a form from the drop-down list, the original header value, and the corrected header value. Once you make your selection and fill in the appropriate sections you can click the submit button. This will generate an that will be sent to the Data Management Unit staff. After the Data Management Unit staff validates the information, the request will be processed and a confirmation sent back to you once the requested update(s) have been made. You can also click the Reset button that will clear out all field information, allowing you to start over. University of Pennsylvania Treatment Research Center, 2010 Page 35

36 Another option of the administrative menu is the Missing Forms link where you can mark forms as missing. This option would be used if you did not collect information pertaining to an instrument for a particular assessment period; you would want to mark those forms as missing in the system. To do this, click on the link Missing Forms from the administration page (Figure 44), that will lead you to a page where you can select the subject you want to mark the missing forms for. (Figure 46) Figure 46 After you pick the subject from the drop down list, a page with all the missing forms for that subject is presented to you grouped by assessment periods (Figure 47). From here you can check the instruments under the assessment period(s) that you want to mark as missing. To complete the process scroll to the bottom of the page and click on the submit button. Once forms have been marked as missing in the system you will no longer be able to select them for data entry. Figure 47 University of Pennsylvania Treatment Research Center, 2010 Page 36

37 There are other reports within the system from which you can get additional information about QA1 and FQA status (Figure 48). Figure 48 Special Instruments This section details a few instruments that do not fit the normal form format: Visual Analog Scales and Continuous forms. Visual Analog Scale: An example of the visual analog scale can be found on the CSSA instrument, this assessment combines a patient administered visual analog scale portion with a technician administered portion. For this instrument the patients is presented with the self-administered VAS questions in html format first (Figure 49). Figure 49 University of Pennsylvania Treatment Research Center, 2010 Page 37

38 The user is presented with the question and a brief explanation on how to control and enter data into the system. Here the user will navigate using the > and < keys to move the marker along the visual analog scale. Once at the desired location on the line, the user can either hit the enter key or click the submit button. There are two VAS in the CSSA instrument. Once completed, the technician portion of the assessment is displayed in Adobe Acrobat format. The information collected from the self-administered portion is already captured within the technician portion of the instrument. The technician cannot alter the selfadministered information during the initial collection period. Modifications to the selfadministered information can occur during the QA phase. There are other kinds of visual analog scales in html format (Figure 50). In this example the user will drag the bar to the position they want to mark and submit the page by clicking on the Continue to next question button. In addition the user can go back to any previous pages to change previous answers. Instrument in HTML format may also use other formatting techniques such as checkboxes or text fields (Figure 51). Once the patient has finished answering all the questions, they can click on the finish button to submit the data (Figure 51). Visual Analog Scales require the use of HTML format to present correctly. This formatting is used specifically for this type of scale, Adobe Acrobat format is the default format for all other assessment types. During the QA process, the data is loaded back in Adobe Acrobat format. Figure 50 University of Pennsylvania Treatment Research Center, 2010 Page 38

39 Figure 51 Continuous forms: Another group of special instruments are continuously formatted forms. Continuous forms are forms that need to be entered continuously across several assessment periods. Some examples of continuous forms would be the Timeline Follow Back, Concomitant Medications, and Pill Count forms. An example of continuous forms can be found in the VNIC study. At the header screen, there is instruction about where you can find all the continuous forms if there are any (Figure 52). In the VNIC study continuous forms are grouped under the week 99 time point. Since the continuous forms span multiple time frames you would enter 99 for the week (time point) no matter which week the patient comes in. After entering the correct header information, you will get the schedule page where you can pick the forms you want to administer. Using Pill Count as an example, click on Pill Count from the schedule page, enter the data from day 1 to day 7 if the patient comes in at week 1 (Figure 53). Submit the data by clicking on the submit button. As usual, you will get a confirmation page; from here you can either Fill out another form or QA now. For the continuous forms do not perform QA1 until you finish entering all the data for this phase. If the study only needs one QA check, then for continuous forms, it has to be QA1 only, not FQA only. Because if it is set as FQA only, once the data is submitted, QA1 is checked, update function is not available any more. University of Pennsylvania Treatment Research Center, 2010 Page 39

40 Figure 52 To resume data collection the next time the patient comes in, login to the data entry system, click on the VNIC study (in this example), and complete the header screen. Here you would enter the header fields and select week 99, date can be any valid date, it will not overwrite the original entry date, a PDF will open with the header information as the first page, and the second page will be the form with the data that you previously entered (Figure 53). From here you can pick up from the data previously entered (this example would be day 7), and start to enter new data. At the bottom of the form, instead of the Submit button, you will see the Update button. To submit the data, click on the Update button. After submitting the data, the previously and newly entered data will be saved. Figure 53 University of Pennsylvania Treatment Research Center, 2010 Page 40

41 Difference between regular and continuous forms: You will be able to make changes to previously enter data via the update function, but the changes that you have made won t be logged and appended to the end of the form. This is different from a regular form where the changes you make during the update process are logged and appended to the end of the form. For the continuous forms, any changes you make before QA1 will not be logged and appended to the end of the form (updating). Changes you make in QA1, QA2 and Final QA will be logged and appended to the end of the form. The other difference between regular and continuous forms is that for regular forms we only allow the same user who administered the form to perform the update and QA1 operations, where for the continuous form we allow different users to perform the update and QA1. Because the continuous form will be administered over a series of time periods it is possible that the user who initially administered the form might leave so other users can continue with the update and QA1 process. The Extend study separates the continuous forms into a different study called ExTend Study TLFB and Pill Counts, some studies group the continuous forms under week 99 in the same study like VNIC, other studies group them under continuous in the same study (Figure 54), other studies do not group them separately, review the instructions at the top of your study header page to know how continuous form are designated (Figure 55). Figure 54 University of Pennsylvania Treatment Research Center, 2010 Page 41

42 Figure 55 University of Pennsylvania Treatment Research Center, 2010 Page 42