We the AIIMS REDCap team, endeavour to provide extensive services to all our users. However, licensing guidelines with the REDCap Consortium necessitate some logical restrictions on service eligibility & access.

1. If you are collecting data for the purposes of human subjects research, review and approval of the project is required by your Institutional Review Board.
2. REDCap is designed for research data entry only. The REDCap server can not be used for routine clinical data collection. For example, clinic registrations, OPD patient data, admission records are beyond the scope of REDCap AIIMS.
3. REDCap is licensed to a specific Institute. Therefore, the services can only be extended to permanent employees of the Institute. The REDCap services cannot be extended to non-Institute researchers and guest faculty. Non-Institute researchers and guest faculty can however, become co-investigators in projects where the PI is from AIIMS Delhi. In such cases, REDCap accounts will be created for them, for the duration of the project only.
4. The responsibility for data security, data privacy, adherence to government regulations belongs solely to the principal Investigator. Adherence to GCP guidelines by all project staff is also the responsibility of the project principal Investigator.
5. The REDCap server is provided to the researchers completely free of cost. Uploading of PDF files and other documents for projects is not allowed in the production server. In case a study requires document upload facility, the principal investigator is requested to contact the REDCap administrators for facilitation of the process. Provision of document store might require project funding support for purchse of server space.
6. The REDCap administrators reserve the right for revoking REDCap credentials of any user, in case of any research misconduct, including usage of the server beyond the official scope.

AIIMS-REDCap is maintained in-house, & its use for research is completely free. Our objective is to help students, residents, scholars, researchers and faculty members use this online platform for research, in a manner that best suits their need.

Note: The AIIMS REDCap team provides the software platform only. The REDCap team will not develop, design or code data entry forms or study instruments. Researchers are requested to visit the resource center in this website to familiarise themselves with the various training materials available. Many universities do provide paid services for developing and managing REDCap projects. We, at AIIMS, currently follow a no-cost, self-help model.

Brief initial hand-holding and departmental trainings are organized by the REDCap Team on request. Kindly contact the REDCap administrators for such programs.

AIIMS-REDCap account is global. ie. once your account is created, it can be used for all activities related to REDCap.To create your account, kindly contact the REDCap administrators or email at redcap@aiims.edu. If you are not a permanent employee of the institute, kindly contact your faculty member to request on your behalf.

At AIIMS, two REDCap servers are in use. The REDCapLive Server and the OrangeCap Training Server.

The main installation (production server) is at the link: https://redcaplive.aiims.edu/. This server is configured with daily image backup, and the REDCap team takes outmost care to maintain its security.

As many users are new to REDCap, AIIMS also runs a training server at the url – https://orangecap.aiims.edu/. Users can create, delete, modify projects at will, and make any number of forms, algorithm and module changes without affecting the ongoing studies by utilizing the OrangeCap server.

For the REDCapLive server, all new projects require authorization from the admin, before they can be created or deployed for production. The facility to request for authorisation is inbuilt in the REDCap software panel. Requests for project authorization, must be accompanied by must also include a permission letter from the Institute ethics board which can be uploaded using the forms here.

As of 2022, training/test projects, which do not have any IRB clearance, are not allowed on the REDCap live server. All such projects should be created on the training server (ORANGECap). The orange cap server is reset every month, to prepare it for training programme and workshops. Therefore, if you wish to retain any project, a copy of such projects should also be downloaded by the user/trainee.

Any form of data for all research that has been approved by the Institute Ethics Committee (IEC) can be hosted on the REDCap platform.

The REDCap platform cannot be used for routine OPD or IPD data collection, clinic data or investigation report collection. In summary, REDCap is a research platform and is not designed to be a replacement of the Patient Information System (PIS) or the Hospital Information System (HIS).

Technically, you can attach and upload any number of documents ( patient reports, scanned documents, photographs) to all REDCap studies. However, the disk-space requirement for such studies are significantly more, and large file uploads may adversely impact the user experience of other members. If your study requires large volume (>100MB) data storage in form of photographs or scans, kindly contact the REDCap administrators so that separate storage solutions can be deployed.

Many universities have published blueprints on citing REDCap as a digital data platform in research. The citation might be required for study proposal, grant application, ethics submission, project reports and during publication. The following boilerplate language is recommended for AIIMS:

Project Writing & Grants Application:

Study data were collected and managed using REDCap electronic data capture tools hosted at the All India Institute of Medical Sciences (AIIMS), Delhi.[1] REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. The REDCap was developed and is maintained by the Vanderbilt University and is licensed to partner institutes free of charge. The AIIMS-REDCap application and data are housed on servers provided by the All India Institute of Medical Sciences (AIIMS), New Delhi. These servers are located within the Institute’s secure data center at AIIMS, New Delhi, India.

Citing REDCap in publications:  Study data were collected and managed using REDCap[1] electronic data capture tools hosted and supported by AIIMS, New Delhi.

Language for redcap access from outside institute: (required for extramural collaborators)
This study will utilize REDCap (Research Electronic Data Capture),[1] a software toolset for electronic collection and management of clinical and research data. The REDCap server at the All India Institute of Medical Sciences (AIIMS), Delhi will be used as a central location for data processing and management. REDCap provides a secure web-based application, with intuitive data manipulation interface, custom reporting capabilities, audit trail functionality, real-time quality monitoring, and has data export/import compliance with most statistical software packages. REDCap is hosted by AIIMS Delhi. (Ansari Nagar, New Delhi, 110029)

Reference:

[1] Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

The AIIMS IEC, in general, is familiar with AIIMS REDCap and the security measures deployed at AIIMS. Study specific information needs to be provided by the investigator for individual ethics application.

Q. If the database is to be maintained locally, what steps have been taken to ensure the privacy and security of the database?

The study database will be created in the REDCap system at AIIMS Delhi and will be hosted in in-premise data centre. Study participants will be allocated a unique study code and identifiers will be masked in the database. Documents linking the study participant to their unique study code will be stored in a locked filing cabinet.

Or as an example for more complex projects:

Participants will be “coded” with a unique study code and personal identifiers will not be used as unique identifiers in REDCap.
Email addresses and other contact information will be stored in the same project database as participant survey responses. This juxtaposition of data elements is required by the REDCap software in order that personalized survey invitations may be emailed to the study participants.
Identifiers will be flagged as such in the REDCap system which then provides additional protection for these data elements.
Identifiers will only be available to specified individuals or user roles.
Identifiers will automatically be removed from all printed or exported materials generated by REDCap where the user has not been given access to identifiers.
Date shifting techniques may be used when exporting and/or reporting data externally so that individuals cannot be identified through dates or birth, clinic visits, etc.
Two-factor authentication will be enabled for the project in order to provide additional security when the application is accessed from outside the AIIMS networks.

Q. Who is responsible for the project data?

The database structure and content will be maintained by the Principal Investigator and the study team. The database software and hardware is maintained by AIIMS, New Delhi.

Q. What protections are taken against inadverdent data loss and system failure?

The AIIMS REDCap team provides daily database backup for the last 30 days. Additionally, the PI of the research team will take daily data backups through the project management interface from the software. In case of catastrophic failure of system, the REDCap server will be restarted from the mirror server with the last 24 hours database.

Q. What steps are taken to prevent misuse of patient data?

REDCap project members are allocated ‘roles’ with different privilages. Only the PI of the research has the right for bulk data downloads. Certain other supervisors will be provided permission to download project data (with or without patient identifiers). In general, data entry officials will not have access to browse or to bulk download data.

In case of multicentric research, data segmentation will be done, with the center investigators having the right to view and download (if needed) center data. No center can have access to the data of any other center.

The REDCap system administrators at AIIMS have access to entrypted data in the server. The data is AES 256 bit entrypted to the id of the PI, and therefore no adminstrator can access or decrypt individual project data.