... User Manual v CECM Clinical Trials

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Edmund McLaughlin
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1 ... User Manual v CECM Clinical Trials

3 T a b l e o f C o n t e n t s i Table of Contents Table of Contents i 2. About Login New Users Logging into study Log out Login issues Password Change Password Reset Password CRFs Navigation Enrol Subjects Search Quick Search Advanced Search CRFs Enter Data Update Data SDV readiness Add Comments Queries Query Status Autogenerated Queries Create queries Search Queries Answer Queries Reissue or Open Queries SDV and Lock Signatures

4 T a b l e o f C o n t e n t s ii

5 1 A b o u t 1 1 About Audience This manual is for the following roles who carry out data entry, query, sign,verify or lock electronic CRFs for CECM clinical trials. 1. Clinicai Research Associates (CRAs) 2. Clinical Research Nurses (CRNs) 3. Principal Investigators 4. Study Monitors 5. Data Administrators

6 2 L o g i n 2 2 Login Contents In this chapter you will cover following topics. 1. New user 2. Logging into study 3. Logging out of study 4. Issues logging in 2.2 New Users All users responsible for ecrfs activities must get unique login ID in one of the following ways During Site Initiation 1. Site specific users will be identified by Trial Coordinator / Monitor during or before site initiation. 2. Login IDs will be created using the details provided and will be passed separately to users by study coordinator Users joining study 1. If you are a new user joining study, contact Study Coordinator to get login details. 2. Login IDs will be created using the details provided and will be passed to user by study coordinator. 2.3 Study Login To log on to study ecrf database: 1. Open any of the following Internet browsers a. Internet explorer ( version 8 and above only ) b. Firefox browser c. Google Chrome d. Safari 2. Enter the study ecrfs web address in browsers' address bar. If web address is not available, contact study coordinator to get details. 3. Login window appears as below.

2 L o g i n 3 Study Login Enter the following details and click on login a. Username : Your login name ( Example: bottla01). If you do not have login name, see section new user to get new login name.

7 2 L o g i n 3 Study Login Enter the following details and click on login a. Username : Your login name ( Example: bottla01). If you do not have login name, see section new user to get new login name. b. Password : Your password. 4. If login is successful, home page is displayed specific to your role. 5. Any issues logging in? See Login Issues for more information. 2.4 Logging out of study Manually logging out of study 1. To log out of study ecrfs database, click on the logout icon ( [a] in the image below ) located at top right corner. Study Logout

8 2 L o g i n 4 2. You will be asked for confirmation. Click 'OK' to logout of study, cancel otherwise Auto logout 1. You will be logged out of study automatically, if no activity occurs for a specific period of time. You must log in again to continue using ecrfs database. 2.5 Login Issues The most frequent issues user may face during logging into ecrfs database and possible solutions are given below Login unsuccessful. Please follow instructions below. This message is displayed under following circumstances a. Received password recently and is not changed by user Every time new password is received it must be changed before logging into database. b. Either username or password is incorrect Check the username and password and try logging into database. Following instructions on login page to reset or change password. c. If you have made too many attempts using wrong password. Your account may have been locked if there are too many wrong password attempts. Contact study coordinator for account or password reset Java script is disabled in your browser. Please enable java script to continue using database. You should have java script enabled in your browser to work with ecrfs. Refer to browser specific instructions on how to enable java script or contact your IT support Unauthorised access / insufficient privileges This message is displayed when you are not assigned any role in the study. Contact study coordinator to get a role assigned to you Internal server error This message indicates something unexpected happened in the database. Try to refresh the page to see if error is resolved. If the message occurs repeatedly contact study coordinator

3 P a s s w o r d 5 3 Password... 3.1 Password Following sections will explain you how to change password or request for password reset. a. Change password b. Reset password 3.2

9 3 P a s s w o r d 5 3 Password Password Following sections will explain you how to change password or request for password reset. a. Change password b. Reset password 3.2 Change password Password criteria Before you begin changing password, make sure the chosen password meet following criteria. a. Password length should be at least 8 characters or more b. Password should contain characters from at least three of the following four categories i. English uppercase characters (A - Z) ii. English lowercase characters (a - z) iii.digits (0-9) iv.special characters (For example:!, $, #, or %) c. New password should be different from last 3 passwords you used Change password To change your password, click 'change password' link (a) on login page. Password Reset A new window opens in the browser with the form to change password as shown below.

3 P a s s w o r d 6 Password Change Form Enter the details as below and click on change password a.

If you forgot password see Reset password c.

Confirm Password : Reenter new password If successful, a dialog appears as follows confirming

10 3 P a s s w o r d 6 Password Change Form Enter the details as below and click on change password a. Account Name : Your account name ( example : bottla01 ) b. Existing Password : Existing password. If you forgot password see Reset password c. New Password : New password that meets the criteria above d. Confirm Password : Reenter new password If successful, a dialog appears as follows confirming password change One of following dialogs may appear to the user, if password change is not successful. i. Password not strong enough. See Password criteria above and try again with new password.

3 P a s s w o r d 7 ii. Incorrect password. Check your password and try again iii.

incorrect user name. Check username entered ( example: bottla01 ) 3.

the following procedures to get new password. 1.

11 3 P a s s w o r d 7 ii. Incorrect password. Check your password and try again iii.new passwords don't match. New password and Confirm password do not match. Retry change password. iv.incorrect user name. Check username entered ( example: bottla01 ) 3.3 Reset password In case you forgot your password or not able to log into study database use one of the following procedures to get new password. 1. Send an from your registered address ONLY to Study IT helpdesk. Helpdesk can be found on the login page as shown below (a) Use subject line Study name : Password Reset for quick resolution.

12 3 P a s s w o r d 8 Password Reset 2. Contact your study coordinator mentioning the issue. Study coordinator arranges password reset on your behalf.

13 4 N a v i g a t i o n 9 4 Navigation Interface Once you log in to database home page is displayed. Different sections of the main page are as follows. a.study Name or Image b.menu c.help d.logout e.login and Role f.site g.quick Search h.crf Navigation i.crf Status icons j.content k.context specific actions Study name or corresponding image List of tasks available to the user. It varies depending on user role Link to ecrfs user guide Link to logout of database Login ID of the user and the role Display user site. Applicable to site users only Form to search subject. Displays list of CRFs when patient visit record is accessed Different status icons applicable to visit / CRF Search results / forms depending on user activity Buttons to perform CRF/Query related actions

14 5 E n r o l S u b j e c t s 10 5 Enrol Subjects Enrol Subject All study subjects must be enrolled before any visit/crf can be started. a. Site users can enrol subject depending on study configuration. If not allowed, site users should contact study coordinator to enrol subject Procedure a. To enrol a subject into study, click Enrol menu link. b. Fill in the form details as follows. All fields marked as '*' are mandatory. a. Subject Number Screening Number for the patient. It is auto assigned by database. b. Registration Date The date of enrolment. It is auto assigned to today's date and user can change the date, if required. c. Date of Birth Date of Birth of the subject. This item value will be validated as per study requirements for Age. d. Gender Subject's gender e. Initials Subject's Initials f. Ethnicity Subject's ethnicity or race

15 5 E n r o l S u b j e c t s 11 g. Other If ethnicity is any Other category, then this item is mandatory h. Country and Site Country and Site for the patient. Not editable for site users c. Click on Enrol button to complete enrolment. d. If successful, a message will be displayed to user with the screening number assigned.

16 6 S e a r c h 12 6 Search Search Study database allow users to search for subject and their visits in following ways a. Quick search b. Advanced search 6.2 Quick search Users can search for patient visits using quick search form. a. Enter patient screening number / trial number to search b. If subject number matches with any existing records results will be displayed. Patient visits are categorised into different groups a.site Site name of the patient. Visible to users based on role. b.groups PreTreatment : Visits such as Screening, Baseline will be categorised into PreTreatment. Treatment : All Treatment visits are included in this category Followup : Includes Followup visits Withdrawal: Includes withdrawal, End Of Treatment or Disease Progression as applicable Toxicity Assessments : Includes Adverse Events Common : Medications fall into this category

6 S e a r c h 13 6.3 Advanced search Users can search for CRFs by Subject number, Site and CRF Status. a. Click Advanced search menu link b.

17 6 S e a r c h Advanced search Users can search for CRFs by Subject number, Site and CRF Status. a. Click Advanced search menu link b. Select the criteria required as follows Site Subject Status List of sites. Available to users based on role List of subjects Check one or more statuses to search for c. Click Search(d) button. List will be displayed matching the selection criteria. i ii Click on Screening number or trial number to view all visits Click on visit name to go to visit

7 C R F s 14 7 CRFs... 7.1 CRFs The following topics will be covered in this section a. Enter data b. Update data c. Indicate SDV Readiness d. Comments 7.

Select the visit you want to enter the data. c. If visit is scheduled or unscheduled, a page will be displayed to record visit date. d. Enter visit date and click Save. e. Click Go to visit to view visit and CRFs.

18 7 C R F s 14 7 CRFs CRFs The following topics will be covered in this section a. Enter data b. Update data c. Indicate SDV Readiness d. Comments 7.2 Enter data To enter form data for a visit follow step below. a. Search for patient visits using Quick search or Advanced Search or from home page ( View visits) b. Select the visit you want to enter the data. c. If visit is scheduled or unscheduled, a page will be displayed to record visit date. d. Enter visit date and click Save. e. Click Go to visit to view visit and CRFs. f. Click on form name you want to complete. g. Complete the form and click Save. h. If successful, a message will be displayed in Yellow i. If content is invalid, error messages will be displayed. j. If the form fails any built in checks, queries will be generated

7 C R F s 15 7.3 Update data To update CRF data for a visit follow the step as per Enter data section. a. To update data, click update button. 7.4 SDV readiness A form can be marked complete if, i.

7.4.1 Changes after Marked Complete i. If there are any changes to the form after marked complete, click Unmark Complete ii. Form will be ready to update iii.

19 7 C R F s Update data To update CRF data for a visit follow the step as per Enter data section. a. To update data, click update button. 7.4 SDV readiness A form can be marked complete if, i. No further changes are expected for the form ii. Form does not have any open queries generated by database To mark form as complete, click Mark Complete button Changes after Marked Complete i. If there are any changes to the form after marked complete, click Unmark Complete ii. Form will be ready to update iii.once updated, remember to mark it complete. 7.5 Add comments Database allows comment to be added to data item of a form.

20 7 C R F s 16 a. To add comment to a data item, click Comment icon against the item. b. Enter data in the comment box and click Add button. c. To update comment, click Update button on the same form.

8 Q u e r i e s 17 8 Queries... 8.1 Queries Queries are generated when edit checks fail or raised by coordinator / monitor during source data verification.

21 8 Q u e r i e s 17 8 Queries Queries Queries are generated when edit checks fail or raised by coordinator / monitor during source data verification. When a query is raised and is not closed, it is displayed on the form underneath data item Following sections will explain the topics related to queries. a. Query status b. Auto generated c. Create queries d. Search queries e. Answer queries f. Reissue or Open 8.2 Query status A query can have any of the following status. a. Opened / Reissued Queries that are open and awaiting response from site users b. Answered Queries that are answered by site users and study coordinator/ monitor can either close the query or reissue c. Closed Queries which are answered by site user and closed by study coordinator/monitor after review 8.3 Auto generated An auto query will be generated if automated edit checks fail for the data item. i. If you update data item and if edit checks are successful, any existing auto queries will be closed. ii. To answer query see Answer queries 8.4 Create queries A user can create query for the data item if they have privileges to create query.

22 8 Q u e r i e s 18 i. Click on create query icon against data item ii. Enter 'Reason' to create query iii.click 'Create' to create query 8.5 Search queries 1. Click Queries menu link 2. Select the criteria as follows to list the queries a.site b.subject Site to list queries for. It is available for privileged users only Subject to list queries for

23 8 Q u e r i e s 19 c.status Choose status ( Open / Closed / Answered ) of query to filter. d.my Queries e.view Check this box to list queries created by you. It is available for privileged users only Click View to run list queries as per the selection criteria 3. Click on the link in red below subject number to view query details 8.6 Answer queries Site users can answer queries as follows i. Open query page using Search queries (as explained in previous section) Or Click on the red link on the CRF/form ii. Fill in the reason box and click Submit to answer query 8.7 Reissue or Open Privileged users can Reissued / Close queries as follows i. Open query page using Search queries (as explained in previous section)

24 8 Q u e r i e s 20 Or Click on the red link on the CRF/form ii. Fill in the reason box, select Reissued/ Closed and click Submit

25 9 S D V a n d L o c k 21 9 SDV and Lock... In this chapter you will cover following topics. i. SDV Search ii. SDV iii.lock CRF 9.1 SDV Search You can search for CRFs based on their SDV status. 1. To search for CRFs, click on SDV link as shown below 2. Use following criteria at the top of the page to search forms. a. Site List of sites. This is available only for CRAs / Study Monitors b. Subject List of subject numbers c. SDV Ready / SDV Partial / SDV Complete / Locked Check one of these boxes to search for (i) SDV Ready : CRFs ready for SDV (ii) SDV Partial : CRFs SDVed partially (iii) SDV Complete : CRFs completed SDV. d. My SDV Records Check this box if you want to list CRFs verified by you f. Require SDV Check this box to only list CRFs that require SDV. e. Search Click on this button once you select your criteria 3. Click on 'Visit' link to start or update SDV. 9.2 Source Data Verification (SDV) When a study is set up, specific visits are designated as SDV required. Users can opt to SDV designated forms or can choose any form to SDV. Forms can be source verified only when following criteria is met. Data entry for the CRFs has been started.

9 S D V a n d L o c k 22 You have privileges to SDV forms. Form is not already verified or it is changed since last verified. 1.

Click on 'Start SDV' (a) button to start SDV 3. Check box appears (c) against each item that can be SDVed on the CRF. a. Click this icon anywhere it appears to select ALL SDV check boxes for items on CRF b.

Click on Apply SDV to apply SDV for items. An icon (a) appears against each item as show in the image below. e. Cancel SDV to cancel SDV process for the CRF 4.

26 9 S D V a n d L o c k 22 You have privileges to SDV forms. Form is not already verified or it is changed since last verified. 1. You can start SDV for a CRF as soon as data entry started for the CRF. Go to required visit or search for CRF using SDV Search. 2. Click on 'Start SDV' (a) button to start SDV 3. Check box appears (c) against each item that can be SDVed on the CRF. a. Click this icon anywhere it appears to select ALL SDV check boxes for items on CRF b. Click this icon anywhere it appears to deselect all SDV check boxes c. Check box to select/deselect individual items for SDV d. Click on Apply SDV to apply SDV for items. An icon (a) appears against each item as show in the image below. e. Cancel SDV to cancel SDV process for the CRF 4. Resultant CRF after SDV looks like below. a. Verified items will have 'verified' icon b. If any item is not SDVed or queries exists for an item, then 'verified icon' will not be displayed

27 9 S D V a n d L o c k 23 c. Start SDV appears only if CRF is partially SDVed. Click this button to SDV remaining items (b) d. Edit SDV : Click this button if you want to change SDV status for verified items. 9.3 Lock Forms when locked prevent users from modifying data. Forms can be locked only when the following criteria is met. form has beem marked complete SDV for the form is complete You have privileges to lock forms. 1. Go to required CRF to perform lock a. Click 'Lock' (a) to lock CRF

1 0 S i g n a t u r e s 24 10 Signatures... 10.1 Signatures Signatures are obtained to confirm that Visits/CRFs are complete and data is not expected to change.

28 1 0 S i g n a t u r e s Signatures Signatures Signatures are obtained to confirm that Visits/CRFs are complete and data is not expected to change. When a study is set up, specific forms are designated as required signatures. 1. Forms can be signed only when they meet following criteria. a. The visit/crf is setup as a signing form. b. All CRFs/forms in the visit are marked complete. c. You have privileges to sign forms. d. Visit is not already signed or it is changed since last signed. 2. To sign a CRF, click Signatures menu link 3. Use following criteria at the top of the page to search forms for signatures. a. Site List of sites and is visible if you have privileges b. Subject List of subject number c. Signed / Sign Ready Check these boxes to search for (i) Signed: signed visits/crfs (ii) Sign Ready: forms to be signed. d. My Signatures Check this box if you want to list forms signed by you e. Search Click on this button once you select your criteria f. Screening Number & Visit Search results : Patient numbers and visit name g. Status Status of signature. If a form require signature, a link ('Sign') will be available to sign. If already signed text will be displayed as 'Signed' 4. Click on 'Sign' link for the CRF you want to sign

1 0 S i g n a t u r e s 25 5. Type password (a) in the password box 6. Click Sign (b) button. 7. If Successful, user will be displayed message 8. Invalid password?

29 1 0 S i g n a t u r e s Type password (a) in the password box 6. Click Sign (b) button. 7. If Successful, user will be displayed message 8. Invalid password? Re-enter the password and click Sign. If you give wrong password a number of times, your account will be locked. Contact study coordinator to unlock your account.

PLATA Data Management User Manual. Version: 1.0

PLATA Data Management User Manual. Version: 1.0 1. Table of Contents 1. Access to the PLATA Data Management environment 3 1.1 Web address and login procedure. 3 2. Features of the ALEA Data Management module 6 2.1 Patient Grid 6 2.1.1. Layouts 9 2.2