InForm Functionality Reference Manual for Sites. Version 1.0

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1 InForm Functionality Reference Manual for Sites Version Mar-2012

2 2012 by Merck & Co., Inc., Whitehouse Station, New Jersey, USA All Rights Reserved No part of this book may be reproduced in any form without the written permission of the publisher, except by Merck & Co., Inc. personnel for corporate use. All other company and product names are used for identification purposes only and may be trademarks of their respective owners.

3 Table of Contents Table of Contents Unit 1 Introduction About this Manual What Is InForm? Logging On Portal Screen Layout Case Books for Sites Page Screen Layout Time and Events Page Screen Layout ecrf Screen Layout Key Icons Unit 2 Screening and Enrolling IVRS vs. Non-IVRS Studies Screening and Enrolling Subjects for a Non-IVRS Study Unit 3 Data Entry Completing the Date of Visit ecrf Assessing Eligibility and Randomization Form Types Flat Forms Repeating Forms Common Forms Completing a Flat Form ecrf Completing a Repeating ecrf Deleting Records on a Repeating ecrf Undeleting Records on a Repeating ecrf Modifying Data Modifying Data on a Flat Form ecrf Modifying Data on a Repeating ecrf Viewing the Audit Trail Unit 4 Query Management Auto Queries vs. Manual Queries Answering Auto Queries Table of Contents.doc 1-Mar-2012 i

4 Table of Contents Changing the Data Value to Address the Query Original Value is Correct Answering Manual Queries Deleting a Record to Answer a Manual Query Unit 5 Comments Why Use Comments? Form-Level vs. Item-Level Comments Creating a Form-Level Comment Deleting a Form-Level Comment Creating an Item-Level Comment Deleting an Item-Level Comment Marking a Form or Field that Contains Data as "Not Done" Unit 6 Associating Data Between ecrfs Automated vs. Manual Associations Associating an Adverse Event and a Concomitant Medication Entering an Associated Record Viewing an Associated Record Removing an Association Between an AE and a Concomitant Medication Manually Associating with Sequence Numbers Unit 7 Unscheduled Visits Adding an Unscheduled Visit Unit 8 Final Status Visit Completing the Final Status Visit Unit 9 esignature Overview Identifying Frozen and Locked Data Performing esignature Changing Data After it Has Been Frozen or Locked Table of Contents.doc 1-Mar-2012 ii

5 UNIT 1: Introduction Unit 1 Introduction Unit Topics About this Manual What Is InForm? Logging On Portal Screen Layout Case Books for Sites Page Screen Layout Time and Events Page Screen Layout ecrf Screen Layout Key Icons Lesson 1.doc 1-Mar

6 UNIT 1: Introduction About this Manual This is the InForm Functionality Reference Manual which corresponds to the InForm for CRCs and for PIs performing Data Entry and esignature (v4.6) e-learning course. This document can be printed and used for later reference after taking the course. What Is InForm? InForm is a web-based electronic data capture tool from Oracle that enables site staff to enter subject data into electronic case report forms (ecrfs). Trial data are automatically stored and maintained on a server database via the internet. Therefore, no data are stored locally. The following steps illustrate the typical activities involved in gathering and storing clinical data using InForm: 1) The individual entering the subject data, either a clinical research coordinator (CRC) or primary investigator, logs on to an InForm trial using a web browser. 2) The CRC or primary investigator completes and submits ecrfs over the internet. 3) The InForm system stores the clinical data from the ecrfs in the InForm trial database. 4) The InForm system then evaluates the clinical data entered and automatically generates queries on questionable data. 5) The CRC or primary investigator answers the queries. 6) The sponsor reviews the clinical trial data. 7) The sponsor may also create manual queries if there are additional questions on any clinical data items. 8) The CRC or primary investigator answers the sponsor's queries. 9) At the end of the study after sponsor review is complete and all outstanding queries have been closed, the sponsor will freeze the data. 10) The primary investigator electronically signs the case record books for the frozen data and the data are locked. Lesson 1.doc 1-Mar

7 UNIT 1: Introduction Logging On One you have been granted access to the production system for your study, you will be sent a URL link via to access that system along with your login credentials. 1) Click the URL address in your . 2) Enter your assigned User ID and Password. After a period of inactivity, the system will ask you for your User ID and Password, but will return you to the screen which you last accessed. Portal Screen Layout When you first log on to the system, you will see the InForm Portal Home Page. On the left-hand side of the screen is the navigation pane which allows you to access the various parts of the system. The MK and Protocol Number will appear at the top of the navigation pane. Use the Logout option on the navigation pane to exit the system securely. Click on your User ID on the navigation pane to change your password. Click on the Study Documents tab to access important documents such as the ecrf Entry Guidelines and InForm job aids. You can use the Find Patient field on the navigation pane to search for a particular subject. If the subject has not been randomized, enter the screening Lesson 1.doc 1-Mar

8 UNIT 1: Introduction number. If the subject has been randomized, enter the randomization number. The number must be entered exactly in order to find a match. The CRF History section displays a quick link to the last 4 ecrfs you accessed. Click on Home in the navigation pane to return to the InForm Portal Home Page. Case Books for Sites Page Screen Layout Clicking on the Patients button on the navigation pane takes you to the Case Books for Sites page. This lists all the subjects enrolled into InForm. If you have access to more than one site, you can select each site using the Site drop-down list at the top of the screen. Do not use the Status drop-down list at the top of the screen as this is not useful for Merck/MSD studies. Click on the Highlight boxes to highlight visits that meet your selected criteria. For example, if you click on the Queries box, traffic lights corresponding to visits for those subjects that have queries will appear active and all other traffic lights will be dimmed. Use the navigation buttons at the bottom of the screen if you have more subjects than can fit on one screen. Click on a subject number in the Patient column to access the Time and Events page for that subject. Click on a traffic light to access the first ecrf for that visit. Lesson 1.doc 1-Mar

9 UNIT 1: Introduction A green traffic light means that all required fields have been addressed on all ecrfs in that visit. A red traffic light indicates there is an open query associated with one or more of the ecrfs in that visit. A yellow traffic light indicates there is missing data on one or more of the ecrfs in that visit. Yellow traffic lights may not be meaningful on this screen if a common ecrf does not contain any data. A snowflake next to a traffic light indicates that the data have been frozen, and a lock indicates that the data have been locked. After data review has been completed by the sponsor, they will freeze the data. The sponsor will notify the Investigative Site that the Primary Investigator should now electronically sign off on the data. After signature, the data will be locked by the sponsor. Time and Events Page Screen Layout Clicking on a subject number in the Patient column on the Case Books for Sites page will bring you to the Time and Events Schedule page for this subject. Click on the Highlight boxes to highlight the ecrfs that meet your selected criteria. For example, if you click on the Incomplete box, traffic lights corresponding to ecrfs for those subjects that have incomplete data will appear active and all other traffic lights will be dimmed. Click on a traffic light to access the ecrf corresponding to that visit. A green traffic light means that all required fields have been addressed. A red traffic light indicates there is one or more open queries associated with that ecrf. A yellow traffic light indicates there is missing data on that ecrf. Lesson 1.doc 1-Mar

10 UNIT 1: Introduction ecrf Screen Layout Clicking on a traffic light on the Time and Events Schedule will bring you to the corresponding ecrf. Use the Visit Timeline at the top of the screen to quickly navigate to another visit. Click on the Yellow Arrow in front of the Visit Timeline to return to the Time and Events Schedule. The subject's screening number will appear in the upper right-hand corner of the screen until the subject is randomized; then the randomization number will appear. Click on an ecrf tab to navigate to another ecrf. A yellow exclamation point on an ecrf tab indicates there is missing data or one or more outstanding queries on that ecrf. An asterisk appears next to required fields. If you leave a required field blank and click Submit, the field will turn yellow, indicating there are missing data on the ecrf. To the right of a field you will see various icons. The icons will vary depending on whether or not the field contains submitted data and the status of that data. Lesson 1.doc 1-Mar

11 UNIT 1: Introduction Icons in the upper right-hand corner of the screen allow you to quickly navigate to other subjects. Click the Navigate by Visit icon to navigate to the same visit for a different subject. A subject drop-down list will appear. Select the subject you want to navigate to. You can access any ecrf in that visit in this mode. Then click the X to close the subject drop-down list. You will remain on the last subject that was accessed. Click the Navigate by Form icon to navigate to the same ecrf for a different subject. A subject drop-down list will appear. Select the subject you want to navigate to. You will only see the current ecrf for the selected subject. Then click the X to close the subject drop-down list. You will remain on the last subject that was accessed. Lesson 1.doc 1-Mar

12 UNIT 1: Introduction Key Icons Navigate to Time and Events Schedule Clear data from an item ecrf Incomplete / Open query No comment on item or form (gray) Comment on item or form (yellow) No query on item (gray) Open or answered query on item (yellow) Query resolved; click to see history (green) No changes to an item (gray) Item changed; click to view audit trail (yellow) Case Book needs signing Case Book has been signed No Lights: ecrf/visit not started Yellow Light: ecrf/visit has missing data Red Light: ecrf/visit has open queries Green Light: ecrf/visit is complete ecrf Frozen ecrf Frozen and Locked Lesson 1.doc 1-Mar

13 UNIT 2: Screening and Enrolling Unit 2 Screening and Enrolling Unit Topics IVRS vs. Non-IVRS Studies Screening and Enrolling Subjects for a Non-IVRS Study Lesson 2.doc 1-Mar

14 UNIT 2: Screening and Enrolling IVRS vs. Non-IVRS Studies Studies utilizing the Interactive Voice Response System (IVRS) to monitor screening and enrollment: Must first enroll the subject into the IVRS system. Screening and enrollment information entered into IVRS is then automatically transferred to InForm. Users will not need to explicitly enroll subjects into InForm and should proceed directly to patient data entry. Studies not using IVRS will need to follow the steps described below to screen and enroll a subject into the InForm system. Screening and Enrolling Subjects for a Non-IVRS Study 1) Click the Enroll button. 2) Click the Add Candidate button. 3) Enter the appropriate information. 4) Click the Enroll link in the Enrolled column. 5) Enter the Screening Number. 6) Click Submit. 7) Click the Enroll button at the bottom of the page. 8) Click the Return button. Warning: Do not attempt to manually enroll subjects into InForm for IVRS Studies Lesson 2.doc 1-Mar

15 UNIT 3: Data Entry Unit 3 Data Entry Unit Topics Completing the Date of Visit ecrf Assessing Eligibility and Randomization Form Types» Flat Forms» Repeating Forms» Common Forms Completing a Flat Form ecrf Completing a Repeating ecrf Deleting Records on a Repeating ecrf Undeleting Records on a Repeating ecrf Modifying Data» Modifying Data on a Flat Form ecrf» Modifying Data on a Repeating ecrf Viewing the Audit Trail Lesson 3.doc 1-Mar

16 UNIT 3: Data Entry Completing the Date of Visit ecrf The first ecrf in every scheduled visit is the Date of Visit (DOV) ecrf. Scheduled Visit Complete the Visit Date for the scheduled visit. If the visit spanned multiple days, consult your ecrf entry guidelines. o Click the Patients button o Click the link for your subject. o Click the traffic light icon for the corresponding Date of Visit (DOV) ecrf. o Use the drop-down lists or the calendar icon to select the date. o Click Submit. Visit Created in Error Once a visit date is submitted and saved, it cannot be erased or cleared. If the visit was created in error, and the visit never occurred for the subject: o Click the check box next to Erroneous Visit. o Click Submit. Lesson 3.doc 1-Mar

17 UNIT 3: Data Entry Assessing Eligibility and Randomization Studies that utilize an Interactive Voice Response System (IVRS) to track screening and enrollment will not need to explicitly enroll subjects into InForm. After enrolling your subject in IVRS, the information will automatically be transferred to InForm. In addition to creating the screening number and transferring the demographic information, IVRS will also populate some information on the Subject Assignment (SA) ecrf. Studies not using IVRS will need to have the entire SA ecrf completed in InForm; however, information on the Demographics (DM) ecrf will be transferred from the InForm enrollment screen. 1) Click on the SA tab. 2) If the subject's screening number needs correction, select Yes, and enter the correct screening number, otherwise, select No. If a new screening number is entered, it must first be verified and approved at Merck to ensure no duplicate screening numbers are created before the change takes affect in the system. 3) If the subject did not meet all eligibility criteria, select No for that question. This will dynamically create the Inclusion/Exclusion Criteria (IE) ecrf. You must access the IE ecrf to indicate which criteria the subject did not meet. 4) If the subject is randomized, select Yes and enter the randomization number. Otherwise, select No and follow procedures for entering a screen failure found in your ecrf Entry Guidelines. 5) Click Submit. Lesson 3.doc 1-Mar

18 UNIT 3: Data Entry You can view Demographics information which was transferred from either IVRS or the enrollment screen in InForm on the DM ecrf. If non-ivrs study data need to be updated, it should be done on the Demographics (DM) ecrf, not the enrollment screen in InForm. For updates to IVRS studies, follow your IVRS guidelines. Form Types There are three types of forms you will encounter within InForm: Flat Forms A flat form is used for data that is collected once during a visit. The Date of Visit ecrf is one example of a flat form. If vital signs are to be taken only once per visit, this will also be collected on a flat form. As soon as you click on the ecrf tab of a flat form, you will see the fields in which to enter data. Repeating Forms Repeating forms allow you to enter multiple records of information. For example, a subject may have multiple medical histories which need to be captured, so the Medical History ecrf would be a repeating form. If a protocol called for vital signs are to be taken multiple times during a single visit, then this would be made a repeating form for that study. When you click on the ecrf tab of a repeating form, you will see the summary view of all records that have already been entered. You must click on the "New" button to enter a new record. Common Forms A common form is a special type of repeating form which allows the records on that form to be entered and viewed from all scheduled visits. This is necessary because certain types of information, such as adverse events and concomitant medication, may span multiple visits. You should enter information on these forms in the visit you first learn of it. Then, if an update is required, such as a stop date, you can access that same record in a future visit, without having to remember the original visit where the record was entered. For example, if you enter an AE record in Visit 3, you will see that same AE record when you access the AE ecrf from any other visit. Lesson 3.doc 1-Mar

19 UNIT 3: Data Entry Completing a Flat Form ecrf On a flat form ecrf, you can see editable fields as soon as you click on the ecrf tab. Complete the applicable fields and click Submit. To clear a particular field, use the eraser icon. On flat form ecrfs you will see the comment icons appear for each field upon opening the form. However, if you enter any data on the ecrf, you must first submit that data before entering any comments. Completing a Repeating ecrf A repeating ecrf allows you to record an unlimited number of records for a given form. When you first click on the tab for a repeating ecrf, you will see the Summary view. If records have already been entered on that ecrf, they will appear here. Lesson 3.doc 1-Mar

20 UNIT 3: Data Entry 1) Click the New button to insert a new record. 2) Complete the applicable fields on the ecrf. On repeating ecrfs, you will not see a comment icon for each field on the details page during initial data entry. If you need to add a comment on a particular field of a repeating ecrf, you must first submit the data, and then the comment icons will appear. 3) Click Submit. Lesson 3.doc 1-Mar

21 UNIT 3: Data Entry Deleting Records on a Repeating ecrf If a record was entered in error and needs to be removed, do NOT simply erase all the data in each field. This will result in a blank record which will be flagged as missing data. Follow the steps below to properly delete a record from a repeating ecrf: 1) From the Summary page, select Delete from the [Select Action] drop-down list at the bottom of the page and click Apply Lesson 3.doc 1-Mar

22 UNIT 3: Data Entry 2) Select the record or records to be deleted by checking the box associated with that record. 3) Provide a Reason for Change. 4) Click Delete. The record will remain on the screen for audit trail purposes; however, a line will appear through the text indicating it has been deleted. Undeleting Records on a Repeating ecrf If you deleted a record in error, you can undelete the record with the following steps: 1) From the Summary page, select Undelete from the [Select Action] drop-down list at the bottom of the page and click Apply. Lesson 3.doc 1-Mar

23 UNIT 3: Data Entry 2) Select the record or records to be undeleted by checking the box associated with that record. 3) Provide a Reason for Change. 4) Click Undelete. Modifying Data If you discover that the data entered into InForm do not match your source documents, you will need to correct the data in InForm. Anytime you modify previously submitted data, you will need to provide a reason for the change. Modifying Data on a Flat Form ecrf 1) Click on the field that requires updating. 2) You will be brought to the Data Values tab. The current field value will be displayed at the top of the screen. The editable field appears in the middle of the screen. Lesson 3.doc 1-Mar

24 UNIT 3: Data Entry 3) Enter or select the correct data. You may first wish to use the eraser icon on the right-hand side of the screen to first clear the field. To clear a field completely and leave it blank you must use the eraser icon. 4) Provide a Reason for Change. 5) Click Submit. Modifying Data on a Repeating ecrf 1) From the summary page of a repeating ecrf, click on the sequence number to access the detail page for that record. 2) Click on the field that requires updating. 3) You will be brought to the Data Values tab. The current field value will be displayed at the top of the screen. The editable field appears in the middle of the screen. 4) Enter or select the correct data. You may first wish to use the eraser icon on the right-hand side of the screen to first clear the field. To clear a field completely and leave it blank you must use the eraser icon. 5) Provide a Reason for Change. 6) Click Submit. You can also delete and undelete individual records when on the detailed page for that record. Use the [Select Action] drop-down list to select Delete or Undelete. Lesson 3.doc 1-Mar

25 UNIT 3: Data Entry Viewing the Audit Trail Any changes to previously submitted data will be tracked in the audit trail along with the corresponding reason for the change, the date the change was made, and the user who made the change. If a field was updated, the audit trail icon will appear yellow Click the audit trail icon to view the field's history. Lesson 3.doc 1-Mar

26 UNIT 3: Data Entry This page is intentionally blank. Lesson 3.doc 1-Mar

27 UNIT 4: Query Management Unit 4 Query Management Unit Topics Auto Queries vs. Manual Queries Answering Auto Queries» Changing the Data Value to Address the Query» Original Value is Correct Answering Manual Queries Deleting a Record to Answer a Manual Query Lesson 4.doc 1-Mar

28 UNIT 4: Query Management Auto Queries vs. Manual Queries If there is a question regarding a particular data point, a query will be issued, either automatically by the InForm system, or manually from a sponsor representative. Auto queries are automatically generated by the system during data entry. After data are submitted, InForm verifies that data against predefined edit checks for the study. If any data values fail an edit check, InForm automatically generates a query for which you need to respond. Auto queries should be addressed immediately to resolve any issues with the data. Manual queries are created by the sponsor as a result of data review activities. Sites should access the Query Listings page on a regular basis in order to search for and address open queries. Timelines for responding to queries will be defined in your ecrf Entry Guidelines. Red traffic lights on the Case Book for Sites page and Time and Events Schedule indicate that there are outstanding queries; however, it is easier to use the Queries button to search for open queries. On the actual ecrf, you will see red, hyperlinked query text describing the issue with the data. A yellow flag icon also appears in the right-hand column next to the field in question indicating a query has been generated. Lesson 4.doc 1-Mar

29 UNIT 4: Query Management Answering Auto Queries When a data value entered on an ecrf fails a pre-defined edit check, an auto query is generated in InForm. Changing the Data Value to Address the Query If the data value was entered incorrectly, you can correct that value. If the new value meets the predefined edit check criteria, the query will automatically close. You will no longer see the red hyperlinked query text and the flag icon will turn green. 1) Click on the data field to access the Data Values tab. If instead you clicked on the red, hyperlinked query text or the yellow query flag, you will be brought to the Queries tab. In this case, you must click on the Data Values tab to be able to modify the data. Lesson 4.doc 1-Mar

30 UNIT 4: Query Management 2) On the Data Values tab, modify the data value and provide a reason for change. 3) Submit the form. 4) If the new data value meets the pre-defined edit check, the query will automatically close and the query flag will turn green. Original Value is Correct If the data value entered is correct per source documents, it should not be changed. However, you still need to address the query by indicated that the original value is correct. 1) Click on the red, hyperlinked query text or the yellow query flag to the right of the field to access the Queries tab. 2) If the valued entered matches the source documentation, select Original Value is Correct. 3) Submit the form. 4) The query status will change to answered and the query will no longer be displayed on the ecrf; however, the query flag will remain yellow. Once the sponsor reviews the response to the query, they can close the query, and the query flag will turn green.. Lesson 4.doc 1-Mar

31 UNIT 4: Query Management Answering Manual Queries Manual queries are generated by the sponsor during the data review process. The Queries button on the navigation pane allows you to search for open queries and is the best tool for managing manual queries. 1) Click on the Queries button on the navigation pane. 2) Selected Opened as the Query Status. 3) Click on the hyperlinked query text for the query you wish to address. The Query tab will be displayed. 4) Review the query to determine whether or not a data change is required in order to address the query. 5) If a data change is required, click on the Data Values tab, update the data, provide a reason for change and click Submit. If the original value is correct, or there is some other reason a data change is not required at this time, select that reason on the Queries tab. If no reason in the drop-down list is applicable, select Other and enter your own reason. If "Other" is selected, any additional details that are entered on the queries tab are not captured within the InForm database. Therefore, if additional information is needed to clarify the data, please add a comment on the data point in question. Lesson 4.doc 1-Mar

32 UNIT 4: Query Management 6) Click Submit. 7) The query status will change to answered and the query will no longer be displayed on the ecrf; however, the query flag will remain yellow. Once the sponsor reviews the response to the query, they can close the query and the query flag will turn green. Only the sponsor can close a manual query. Deleting a Record to Answer a Manual Query If you need to delete a record in order to resolve a manual query, you must first answer the query and then delete the record. It must be done in this order or else the open query will remain and you will not be able to get back to that query to mark it answered or closed, unless you undelete the record. 1) Once you determine that you need to delete a record in order to resolve the query, make sure you are on the Queries tab. 2) Select Other and indicate that you will be deleting the record. 3) Click Submit. 4) Locate the record you need to delete on the Summary page of the ecrf. Lesson 4.doc 1-Mar

33 UNIT 4: Query Management 5) Select Delete and click Apply. 6) Select the record or records you need to delete, provide a reason, and click Delete. 7) The deleted record will now appear on the Summary page with a line through it. Lesson 4.doc 1-Mar

34 UNIT 4: Query Management This page is intentionally blank. Lesson 4.doc 1-Mar

35 UNIT 5: Comments Unit 5 Comments Unit Topics Why Use Comments? Form-Level vs. Item-Level Comments Creating a Form-Level Comment Deleting a Form-Level Comment Creating an Item-Level Comment Deleting an Item-Level Comment Marking a Form or Field that Contains Data as "Not Done" Lesson 5.doc 1-Mar

36 UNIT 5: Comments Why Use Comments? Comments are sometimes necessary to clarify data points or to indicate that certain data was not collected. If required data was not collected you must use the Not Done, Not applicable, or Unknown radio buttons on the comments screen so that your ecrf is not marked as having missing data. Form-Level vs. Item-Level Comments Form-level comments are associated with an entire ecrf, while item-level comments are associated with a specific field or data point. Comments should be entered only when necessary. Written comments should provide an explanation only and should not contain any new data. Creating a Form-Level Comment The icon for creating form-level comments is located in the upper right-hand corner of the screen next to the patient number. It is available on a flat form or the details page of a repeating form. Lesson 5.doc 1-Mar

37 UNIT 5: Comments 1) Click on the blue, form-level comment icon on the ecrf. 2) Enter comment and/or select the radio button indicating the reason the form was not completed. 3) Click Submit. 4) Click OK. 5) Click Return to return to the ecrf. Not Done, Not Applicable, and Unknown options are only available on forms that are completely blank. Most ecrfs in scheduled visits are expected to contain data. If there is no data to report (and it will never be attainable), a comment indicating Not Done, Not Applicable or Unknown may be required. Not Done, Not Applicable and Unknown should not be used for data that is temporarily missing. If the data will be available at a later date, leave the field blank and come back to it when the data is known. Consult the ecrf Entry Guidelines for specific details for a given study. You will not see a form-level comment icon on the summary page of a repeating form. This is typically because most repeating forms do not require data entry if there is nothing to report. Common forms, such as Adverse Events (AE), Concomitant Medication (CM) and Procedures (PROC), are repeating forms that do not require an entry if there are no data to complete on that ecrf. Common forms contain data that are applicable across visits. They appear in and are accessible from every visit. However, most repeating forms in scheduled visits are expected to contain data. If there is no data to be entered on a repeating form in a scheduled visit, consult the ecrf Entry Guidelines on how to handle this issue for a given study. Always consult the ecrf Entry Guidelines for the most accurate instructions for recording data for a specific study. Deleting a Form-Level Comment If a form-level comment has been entered indicating the form was not done, you cannot enter data into the fields on that ecrf. If data become available at a later time, you must clear out the Reason incomplete indicator on the comments screen in order to allow data entry into the fields. 1) Click on the blue, form-level comment icon on the ecrf. 2) To clear comment text, highlight the comment text and press the Backspace or the Delete key. Lesson 5.doc 1-Mar

38 UNIT 5: Comments 3) To clear the Reason Incomplete indicator, click on the eraser icon to the left of the field. 4) Click Submit. 5) Click OK. 6) Click Return to return to the ecrf. Creating an Item-Level Comment The icon for creating item-level comments is located to the right of each field on the ecrf. 1) Click on the comment icon to the right of the field to which you wish to add the comment. 2) Enter the comment and/or select the radio button indicating the reason the form was not completed. 3) Click Submit. 4) Click OK. 5) Click Return to return to the ecrf. Not Done, Not Applicable, and Unknown options are only available on fields that are completely blank. Deleting an Item-Level Comment If an item-level comment has been entered indicating the data point was not collected, you cannot enter data into that field. If data becomes available at a later time, you must clear out the Reason incomplete indicator on the comments screen in order to allow data entry into that field. 1) Click on the comment icon to the right of the field from which you wish to delete the comment. 2) To clear comment text, highlight the comment text and press the Backspace or the Delete key. 3) To clear the Reason incomplete indicator, click on the eraser icon to the left of the field. 4) Click Submit. Lesson 5.doc 1-Mar

39 UNIT 5: Comments 5) Click OK. 6) Click Return to return to the ecrf. You will NOT be able to clear a comment from a data point or form that currently contains data. If you attempt to highlight the comment, press the backspace key and click submit, you will receive the following error message: You can only clear the comment field when you are selecting one of the Not Done, Not Applicable, and Unknown options. If a comment becomes no longer applicable, and you are unable to remove it completely, simply replace the comment text with "N/A", an "x", a ".", or something similar in order to replace the invalid comment. Since some comments cannot easily be removed, only enter comments if you do not expect to delete them at a later time, and only if they provide benefit in clarifying the data on the ecrf. Marking a Form or Field that Contains Data as "Not Done" Not Done, Not Applicable, and Unknown options are only available on the Comment page of forms or fields that are completely blank. To mark a field as not done that contains data, you must first erase the data value in that field. To mark an entire form as not done that contains data, you must first individually erase all fields that contain data on that form. Refer to the directions in the sections above for deleting comments and/or removing the Reason incomplete indicator. Lesson 5.doc 1-Mar

40 UNIT 5: Comments This page is intentionally blank. Lesson 5.doc 1-Mar

41 UNIT 6: Associating Data Between ecrfs Unit 6 Associating Data Between ecrfs Unit Topics Automated vs. Manual Associations Associating an Adverse Event and a Concomitant Medication» Entering an Associated Record» Viewing an Associated Record Removing an Association Between an AE and a Concomitant Medication Manually Associating with Sequence Numbers Lesson 6.doc 1-Mar

42 UNIT 6: Associating Data Between ecrfs Automated vs. Manual Associations There are two ways in which data can be associated in InForm. The first is an automated process where the system displays both ecrfs on which to make the associations. The second is a manual process where you must remember the sequence number generated on one ecrf and enter that number onto another ecrf. Associating an Adverse Event and a Concomitant Medication Associations between adverse events (AEs) and the concomitant medications (CMs) used to treat them are done using the automated association process within InForm. These are also common forms. That means you can access these forms from any visit, and any data you enter on these forms will be available in all the visits. Although automated associations are most commonly used with the AE and CM ecrfs, other ecrfs may utilize this functionality depending on your study. Please see the protocol specific ecrf Entry Guidelines for more details. Entering an Associated Record 1) After you click Submit to save an adverse event on the AE ecrf, the InForm system will display the Concomitant Medication (CM) ecrf at the bottom of the screen in a split-screen mode. Conversely, if you first submit a concomitant medication on the CM ecrf, the system will display the AE ecrf at the bottom of the screen in a split screen mode. 2) Click New on the bottom ecrf to enter the associated record. Any records you enter on the bottom part of the screen will be automatically associated with the record on the top half of the screen. 3) Click Submit to save the associated record. 4) If you click Return, it will return you to the split-screen view and allow you to associate additional records. Lesson 6.doc 1-Mar

43 UNIT 6: Associating Data Between ecrfs Viewing an Associated Record When viewing the ecrfs in the split-screen mode, you can choose to see all records entered for the ecrf at the bottom of the screen by selecting Show All, or only those records that are associated with the record at the top of the screen by selecting Show Selected. Records on the bottom ecrf that are associated with the record on the top ecrf will display a check mark in the box to the left of the record. On the summary view of the AE or CM ecrf, if you scroll all the way to the right, you will see the sequence numbers for the associated records in the association column. Lesson 6.doc 1-Mar

44 UNIT 6: Associating Data Between ecrfs Removing an Association Between an AE and a Concomitant Medication If you realize that an association between an adverse event and a concomitant medication was made in error, you can disassociate the record by removing the check mark. 1) Click the sequence number of the record that has the inappropriate association. 2) Click the check box of the record you want to disassociate. This will display the record in update mode. 3) Click the checkbox to remove the check mark. 4) Enter a Reason for Change. 5) Click Submit to save the change. Manually Associating with Sequence Numbers Some ecrfs allow you to manually associate records from different ecrfs by entering the sequence number for a record from one ecrf onto the other ecrf. For example, the procedure which was used to diagnose an adverse event can be linked to that AE by entering the AE s sequence number onto the PROC ecrf. 1) On the first ecrf, note the sequence number of the record to be associated. 2) Navigate to the second ecrf. 3) In the field to capture the associated sequence number, enter the number you noted from the first ecrf. 4) Click Submit to save the data. To remove this association you must erase the sequence number that was manually entered on the second ecrf. Lesson 6.doc 1-Mar

45 UNIT 7: Unscheduled Visits Unit 7 Unscheduled Visits Unit Topics Adding an Unscheduled Visit Lesson 7.doc 1-Mar

46 UNIT 7: Unscheduled Visits Adding an Unscheduled Visit If the subject has an exam or procedure that occurs between regularly scheduled visits for the study, you may need to create an unscheduled visit in order to enter this information into InForm. 1) Access the Unscheduled Visit. Either select Unscheduled from the Visit Timeline when viewing other ecrfs, or click on the Unscheduled traffic light on the Case Books for Sites page or the Time and Events Schedule. 2) On the DOV ecrf, enter the date of the unscheduled visit. 3) Select the ecrfs on which you need to enter data. 4) Click Submit. The ecrf tabs for selected ecrfs and common forms will be generated. 5) Complete the appropriate ecrfs. 6) If additional unscheduled visits are required, click the New button in the bottom left-hand corner of the screen and enter a date for the new unscheduled visit. 7) You can switch between unscheduled visits by using the drop-down list next to the New button. Lesson 7.doc 1-Mar

47 UNIT 8: Final Status Visit Unit 8 Final Status Visit Unit Topics Completing the Final Status Visit Lesson 8.doc 1-Mar

48 UNIT 8: Final Status Visit Completing the Final Status Visit Whenever a subject screen fails, discontinues early, or completes the study you will need to complete the appropriate forms in the Final Status Visit. The ecrfs and the data collected in the Final Visit will vary depending on the study. Refer to the ecrf Entry Guidelines for your study for more details. 1) Access the Final Status Visit. Either select Final Status from the Visit Timeline when viewing other ecrfs, or click on the Final Status traffic light from the Case Books for Sites page or the Time and Events Schedule. 2) Complete an End of Study Disposition (DS) ecrf for the subject. If the subject completed the study, select Completed. If the subject was a screen failure or discontinued early, select Discontinued and also select the applicable reason. The list of reasons will differ depending on the study. Be sure to scroll down and answer all the questions on this ecrf. 3) Click Sumbit. 4) Complete the other ecrfs in this visit as per your ecrf Entry Guidelines. Be sure to refer to your ecrf Entry Guidelines for completing information in the Final Visit for your study. Lesson 8.doc 1-Mar

49 UNIT 9: esignature Unit 9 esignature Unit Topics Overview Identifying Frozen and Locked Data Changing Data After it Has Been Frozen or Locked Performing esignature Lesson 9.doc 1-Mar

50 UNIT 9: esignature Overview After all data have been entered and all queries have been addressed, the sponsor will freeze the data in the InForm system. At this time, no further changes can be made to the data. The primary investigator, or their designee, is then responsible for approving the accuracy and completeness of the subject's data by electronically signing the Case Records Book for each subject. Once esignature has been obtained, the data will be locked by the sponsor. Identifying Frozen and Locked Data Frozen data can be identified on the Case Books for Sites page and the Time and Events Schedule by the blue snowflake icon that appears next to the traffic light. Locked data can be identified by the blue lock icon that appears next to the traffic light. Frozen Data Locked Data After data review has been completed by the sponsor, they will freeze the data. The sponsor will notify the Investigative Site that the Primary Investigator should now electronically sign off on the data. After signature, the data will be locked by the sponsor. Lesson 9.doc 1-Mar

51 UNIT 9: esignature Changing Data After it Has Been Frozen or Locked If changes to frozen or locked data are required: 1) The site should contact their Clinical Research Associate (CRA). 2) The CRA will then request that the data be unfrozen or unlocked by headquarters personnel. 3) The site can then make the appropriate modification to the data and inform the CRA when it is complete. 4) The CRA will then contact headquarters to re-freeze or re-lock the data. If an esignature had already been applied to a subject before the change, the Primary Investigator will need to re-sign after the data has been re-frozen. Performing esignature The primary investigator will have all of the same data entry rights as the clinical study coordinator (CRC); however, the investigator, or his or her designee, has the sole responsibility for signing off on the subject data. 1) Click the Signatures button. 2) Click the Sign Book link for the subject to which you wish to apply your electronic signature. Lesson 9.doc 1-Mar

52 UNIT 9: esignature 3) Enter your User Name and Password in the appropriate fields. 4) Click Submit. If the primary investigator wishes to review any data prior to applying an electronic signature, he or she may do so by clicking on the traffic light on the Signatures page, which displays that subject's Time and Events Schedule. You can also review subject data via the Patients button. Lesson 9.doc 1-Mar

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