Data Review, Monitoring, and Signatures

Conducting review of data, including monitoring and applying electronic signatures

The ability to review CRFs is configured up by the Study Administrator. The rules applied to each study can vary. This article will cover review process in a common configuration for both a Monitor reviewer and an Investigator signature. Use one of these links to jump to the applicable section:

Reviewing or Monitoring Without Field Source Verification

Batch Review

Monitoring With Field Source Verification

Applying Signature

Unlock Records

Historical Listings and Monitoring Report

FAQs


Reviewing or Monitoring Without Field Source Verification

Prerequisite: User has the role assigned to a given review level and has access to Action Items Report.

The easiest place to see all records ready for review at a given level is the Action Item Report. This can be accessed on both the web browser and mobile app.

Web Browser:

AIW1

From here, you may or may not see all the sections below, depending on your permissions. Tap the section header to expand the list of records ready for review at that level.

RecRev1

Mobile App:

AIWM

From the list you can filter by site, select forms to open/review, or batch select for performing bulk actions. If these are not available, the permissions may not be set correctly.

AIWR2

You will see the option to mark a record as reviewed when the form is open. 

Web Browser:

Tap the confirm review button at the bottom of the form. Once that is done, you may be redirected to the action items report if that is where you are working from. Otherwise, the review history will be displayed at the top of the form that was reviewed. If you are not redirected to the action items, use the link at the bottom right side of the screen.

AIWR3

Mobile App:

Tap the Review Icon in the toolbar at the top of the form. In this example, the icon contains a value of "1" - meaning the record is being reviewed at the first workflow level. 

AIWR3Mob

Reviewed status icons

The record status icons will indicate which level records have been reviewed.

ReviewIcon1

Mobile App:

Here's an example a a subject's casebook on the Mobile App.


Batch Review/Locking

Records can be marked as reviewed more quickly in batches without opening up each form.

Prerequisite: Access to Subject Record Management - Batch lock and sign records

 

Web Browser:  This can be done in the action items report by selecting a group of records and then tapping the batch review button at the bottom.

Volume Batch Locking

Web Browser:

To easily review ALL records for a given site and form, there is a separate function available, depending on the permissions granted. It allows for batch reviewing an entire list of records for a given form without selecting groups at a time from the action items report.

Prerequisite: User must have access to Subject Record Management - Volume batch record lock

When enabled, users will see this option on the Subject Manager screen on the web browser:
VBRL1

When use, the user will be presented with options to select a site, form, and level that records should be locked at. The current user will be limited to their own sites and assigned review level.

VBRL2

Once executed a number of records locked will be displayed for reference.

This function does not check which forms are omitted from review levels. For example, if the Registration form is omitted from Investigator review in the study design, the action items report will account for that, but the volume batch lock function will not. In other words, the Investigator would still be able to sign off and lock all Registration records at their own level.


Monitoring With Field Source Verification

Some forms may require source data verification before the whole form can be marked reviewed.

Prerequisite: User's role must be assigned to the same workflow level that is configured to perform field source verification.

All required fields must be source verified (locked) before the form can be reviewed and progress to the next workflow level. Those fields can be seen when the form is open.

Web Browser:

In the image below, the highlighted field has not yet been locked. Until doing so, the form as a whole cannot be marked reviewed and locked. Instead, only the specific fields are locked.

Click on the Lock icon to SDV and lock that field. 

FSVex1

Mobile App:

Tap and hold the lock icon next to the field for 1 second.

FSVexm1


The button at the top of the page, "Lock Fields" also provides a quick option to lock all applicable fields on the page. This can be helpful when many fields exist on the page. If queries then need to be added, just tap on the needed fields to unlock those again to add queries.

Web Browser:

FSVallweb

 

Mobile App:

FSVallmob

When fields are locked, data entry personnel will only be able to change the data in those fields if they have the Field Unlock permission, granted by a Study Administrator.

As fields get locked, they will get stamped in the Field Lock Report.


Field Lock Report

This report is a good way to see all fields that are either awaiting lock or have been locked (i.e. SDV history and outlook)

Prerequisite: User has access to the Monitor Report

The Field Lock Report displays the defined data fields which are either awaiting review or have been reviewed (locked).

It can found under the Reports menu. Any user role with access to the Monitor Report will also have access to the Field Lock Report.

A table similar to below will display:

FLockReport1

To see which fields are awaiting lock, filter the status dropdown to "Unlocked" records. 

To see a list of what historical work has been done, filter the list by the status "Locked" records.

FLSV Date is the date when the field was last locked.


Applying Signature

Records progressing through the review levels defined on a study often require eSignatures at one or more levels. This is commonly done by a Site Investigator as a final review step but can differ among studies.

Records available to review can be accessed via the Action Item Report on both the Web Browser and the Mobile App as described in the first section of this article.


Once a record is marked as reviewed, if it requires signature, you will see a popup window requiring electronic signature. This is done by using sign in credentials on the web browser, or by handwritten or biometric signature on the mobile app.

 

Mobile App:



There are three methods for providing eSignature within TrialKit:

  • Traditional username/password entry - Web browser and mobile app
  • Handwritten (Analog) signature - mobile app only
  • Biometrics - mobile app only on devices with biometric support

On the signature window in the Mobile App, the handwritten option will be the default. Biometric or Sign In option can also be selected if preferred and if the device supports biometrics.

When a signature is provided the system logs the event, user, date, and signature type utilized. This information is presented in audit trails with other information.

Batch Signatures

To perform review and signatures in batches, or to bypass record sign off on subsets of records are functions that can only be performed if the user’s role has been granted the corresponding permissions. Batch and bypass review can be done from the Action Item Report.


Unlocking Records

By default any user role responsible for a given review level can unlock that same level if it is the most recent review level performed. If the record has progressed to other levels, the user will need the Unlock Record permission, granted by a Study Administrator, to unlock other review levels.

Study Administrators, or other users with access, can batch unlock records from the Study Events Report.


Monitor Report and Reviewed Records Listings

To see a history of what records have been reviewed, there are a couple reports available:

  • Dashboard report
  • Record Status Report
  • Monitor Report (specific to the first review level)

For the first review level, the Monitor Report will show what is awaiting or has been monitored. This is especially helpful for studies where two initial passes are being done on records, referred to as a "soft" review.

Prerequisite: User has access to the Monitor Report

The report shows lists of records that:

  • Are ready for review
  • Have been either Monitored (first workflow level) or initially verified
  • Have been changed since initial review, depending on site permissions to make changes
  • Records ready for final review/lock

There are also several filters so Monitors can produce lists of what needs to be monitored or the work they have done during specified time periods. Those lists can also be exported to Excel from both the Web Browser and the Mobile App.

Access the Monitor Report under the Reports menu from both the Web Browser and Mobile App.

Web Browser:

MRmenu1


Mobile App:

Located in the Reports menu.

FAQs

I don't see the option to mark a form as reviewed. What factors are there to consider?

  • Your role is assigned as a reviewer
  • The record has either been reviewed at the previous level, or if it's the first level the form does not have any open queries
  • There are still fields on the form that require source verification
  • The form is omitted at specific review level(s)

Monitors want to mark a form as reviewed even though there are open queries to address. How is this done?

The study Administrator must configure the review level for "Soft" review. This will allow for marking forms as reviewed even though queries still need to be resolved.