Clinical Data Systems FAQs

Our Clinical Trials Unit provides Electronic Data Capture services using industry-standard systems (REDCap and OpenClinica).

At the heart of our service is our specialist team who provide expertise in database design, validation, and support throughout your study.

To ensure sustainable delivery of these services, we operate on a cost-neutral basis. The fees we charge cover essential operational costs and directly support our specialist team, enabling us to maintain the expertise needed to set up and run your studies effectively.

We encourage researchers to include EDC costs in grant applications and can provide detailed costings and justification for funders.

For specific quotes or to discuss your study's requirements, please get in touch: cds_services@imperial.ac.uk

If you're experiencing a technical issue or believe you've found a bug in OpenClinica, please reach out to our support team at cds_support@imperial.ac.uk.

When you contact us, please provide a clear description of the problem, including the steps you took that led to the issue. If possible, attaching screenshots can be very helpful for us to understand and resolve the problem quickly.

Data retention policies vary depending on the specific requirements of each clinical trial's sponsor and funding organization, with retention periods typically ranging from several years to decades after study completion. Upon completion of the study we will provide the study team with a copy of the database for archiving.

Please request data extracts by emailing cds_support@imperial.ac.uk.

You will be asked to complete a form specify the data and the format. Currently we are able to export to the following formats: Excel, HTML, SPSS, or SAS.

Study teams may wish to temporarily freeze the database, for example, as in the case of an interim analysis. This is done by completing a request form and sending it to cds_support@imperial.ac.uk.

When ready to resume data entry, the same form should be used to request that the database be unlocked.

For final locked data: The Study Team is required to submit a Hard Lock Request Form confirming the approval for database hard lock. The form includes a checklist to be completed and signed by the Chief Investigator. At the end of the study the database will be hardlocked and all user accounts are terminated with the exception of those identified as requiring read only access for reporting and review purposes. The decision to unlock a previously hardlocked study database should be done only in exceptional circumstances and will be made in consultation with ICTU Senior Management after consideration of regulatory and procedural requirements for reporting.

For OpenClinica: please go to the login page and click on the "Don't remember your password?" link: https://auth.openclinica.io/auth/realms/imperial/login-actions/reset-credentials

For REDCap: please go to the login page and click on the "Forgot your password?" link: https://redcap.imperial.ac.uk/redcap_v15.0.7/Authentication/password_recovery.php 

Follow the instructions provided to reset your password.

If you have tried resetting your password and are still unable to log in, please contact our support team for further assistance by emailing cds_support@imperial.ac.uk . We aim to respond to password reset issues within 1 business day.

As an enhanced verification measure, we enable Multi-Factor Authentication (MFA) in OpenClinica to increase the security of your user account by requiring a time-sensitive code from an authentication application, like Google Authenticator, in addition to your password.

To set up: When you first log into OpenClinica, after entering your username and password, a QR code will appear on your screen. Open the Google Authenticator app on your device, tap the "+" icon (or "Add a code"), select "Scan a QR code", and use your camera to scan the QR code displayed on your computer screen.

Once scanned, the OpenClinica account will be added to the app, providing you with time-sensitive login codes. If your authentication code is not working, please email our support team (cds_support@imperial.ac.uk) and the team will be able to reset this for you. We will notify you when the reset is complete and you will  then be asked to log into OpenClinica, where you will be presented with a new QR code to scan with your authentication application on your mobile device.

You can remove or restore a participant from a study database by using the administer subject tool in OpenClinica. Ensure all required approvals are in place prior to removal.

Please refer to the OpenClinica guide: https://docs.openclinica.com/3-1/brief-overview/administer-subjects/administer-subjects-remove-subject/. If you're unable to locate a recently added participant, first check the filter settings in the top right corner of the participants page in OpenClinica and select 'All Records' to ensure no filters are limiting your view. If the participant still doesn't appear, check if your site is at its expected number of participants by viewing site details, as this may affect participant visibility or enrollment capacity.

If issues persist, contact CDS Support (cds_support@imperial.ac.uk) to verify whether your study has reached its maximum participant enrolment limit, which would prevent additional participants from being displayed.

To create a REDCap project for your study, please refer to the following guide: https://www.imperial.ac.uk/clinical-trials-unit/clinical-data-systems/redcap/ 

All the required forms, events, and casebooks in OpenClinica must first be signed.

Database Hard Lock and the Data Extract request forms are submitted to our support team (cds_support@imperial.ac.uk), who will then extract the full research data extract and the Archival Casebook to the nominated individual.

The Study Manager, or their delegate, will be able to download the Case Report Book for each participant in their study from OpenClinica.

We will archive the study in OpenClinica one month after Database Hard Lock.

For new study database builds, please contact cds_services@imperial.ac.uk.

For any changes to your live study, please get in touch with us by emailing cds_services@imperial.ac.uk.

We aim to acknowledge receipt of your request within 1 business day. The time to assess the scope of the changes and provide feedback will vary depending on the complexity but we aim to respond with an initial assessment within 3-5 business days.

When requesting a new study database build, it's helpful to provide your study protocol, even if only in draft form. While not mandatory at the initial request stage, sharing the protocol allows our team to better understand your study design and user requirements.

Signing casebooks in OpenClinica can only be performed by users with Principal or Chief Investigator roles.

Before signing, ensure all required forms within an event are marked as complete and all queries have been resolved. You can sign participant records either in bulk through the study matrix or individually for both visit events and common events.

For detailed instructions with visual guidance, please refer to the OpenClinica documentation at: https://docs.openclinica.com/oc4/using-openclinica-as-an-investigator/oc4-reviewing-and-signing-subject-records/ 

OpenClinica's email notification system is based on rules. This means we can configure it to automatically send out notifications whenever a particular action occurs, e.g. Randomisation with kit allocation or an Adverse Event.

When we create your study database, our team will work with you to understand your notification needs, set up the appropriate rules, and thoroughly test them to ensure they're working correctly.

For studies where a member of the team has an Imperial College London email account, please request the study inbox is created by your Departmental ICT Contact person: https://www.imperial.ac.uk/admin-services/ict/self-service/connect-communicate/email/request-accounts/. Where this is not the case, please contact your local ICT Department.

We recommended a study inbox is setup prior to UAT so that notifications can be tested.

OpenClinica allows users to flag potential data issues on eCRFs, which are recorded as queries. These queries, along with any related annotations and reasons for change, are displayed in the OpenClinica Queries Table. Queries can be assigned to study team members for review, and monitoring metrics are automatically generated.

To learn more about queries please refer to OpenClinica's documentation: https://docs.openclinica.com/oc4/help-index/study-runner/submit-data/queries/ 

When we set up your study database, we will also include a standard set of monitoring reports. These reports have been developed by ICTU's Central Monitoring Working Group. Furthermore, we can customize these standard reports to specifically focus on your study's primary endpoint and any other particular monitoring needs you might have.

OpenClinica features comprehensive built-in audit trail functionality that provides detailed logging at both the individual participant and overall study level. All user activities and data changes are automatically recorded and tracked, with complete audit information accessible through the Insight tool for comprehensive reporting and compliance monitoring.

We recommend the study team undergoes training early in the project, usually around the time when requirements are being defined. This ensures that when the database has been created, the various users can participate effectively in testing.

For access to OpenClinica training materials, please visit: https://www.imperial.ac.uk/clinical-trials-unit/clinical-data-systems/cds-openclinica/training-openclinica-40/.

If you need to locate a training certificate for a user who has completed the required OpenClinica training, please contact our CDS Support team (cds_support@imperial.ac.uk). All training certificates are securely stored but we can provide them upon request.

OpenClinica documentation is available here: https://docs.openclinica.com/oc4/ 

A Site Activation Form (SAF) should be completed whenever a new study site, which is a location where participants will be recruited or examined, needs to be added to the system.

Similarly, a User Activation Form (UAF) should be completed for each new member of the study team who will be involved in interacting with the study database in OpenClinica.

Email our support team cds_support@imperial.ac.uk for these forms.

Please note that the Chief Investigator can sign the User and Site Activation Forms if/ when your Study Manager is unavailable.

If your Project Manager is unable to add new users to REDCap, please email our support team (cds_support@imperial.ac.uk) with the following information:

• For external users: their full name and complete email addresses.
• For Imperial College users: their full names.

Once our support team has added these users to the system, your Project Manager can then assign them to specific projects and set appropriate user roles.