REDCap Cloud (RCC) for Part 11 Regulated Research
Under FDA 21 CFR Part 11 (“Part 11”), eSignatures and electronic records must be managed in validated systems. REDCap Cloud (RCC) is a validated electronic data capture (EDC) platform that supports eConsent; surveys; and integration with EHRs, wearables, mobile apps, and other data sources. nPhase, Inc. is the vendor for RCC and is responsible for maintaining regulatory compliance of RCC and for providing documentation to support compliance. RCC is approved for use in WashU research studies, including but not limited to the following:
- Research studies capturing protected health information (PHI) and/or personally identifiable information (PII).
- Commercial or non-commercial investigator-initiated Part 11 regulated clinical trials.
- This is typically drug and/or device trials with any of the following Biologics License Application (BLA), Abbreviated New Drug Application (ANDA), Investigational New Drug (IND), and/or Investigation Drug Exemption (IDE).
- Clinical trials at all levels of risk to patient safety and data integrity.
Trial-CARE serves as the WashU tenant administrator for RCC, and research teams interested in using RCC should contact Trial-CARE at TrialCare@wustl.edu to learn more and/or to create a scope of work (SOW) to use RCC. For more information about the tiered product packages and general pricing structure of RCC, click here.
Once a scope of work (SOW) is in place with RCC, the study team must complete the WashU Office of Information Security (OIS) FDA Part 11 Security Plan to obtain approval to use RCC for participant data collection. Trial-CARE can assist research teams with the completion of the WashU OIS FDA Part 11 Security Plan, and has put into place a package of support for the use of RCC in compliance with the WashU OIS FDA Part 11 Security Plan.
The Trial-CARE Support Package for RCC Alignment to Part 11 Regulations includes:
RCC system configuration-level
- Standard Operating Procedures (SOPs)
- System Configuration Requirement Specifications
- Software Configuration Validation Plan
- System Configuration Test Plan
- Checklists and Test Scripts
- Validation Summary Report
Study-level
- Master Policy for Alignment to Part 11
- Checklists and Test Scripts
- Validation Summary Report
- Trial-CARE offers a free 60-minute consultation.
- Use of the Trial-CARE Support Package for RCC Alignment to Part 11 Regulations is fee‑based. Costs are scoped in advance with your team and designed to fit within your study budget.
To learn more, contact Trial-CARE at TrialCare@wustl.edu.
- Trial-CARE offers a free 60-minute consultation.
- Use of the Trial-CARE Support Package for RCC Alignment to Part 11 Regulations is fee based. Costs are scoped in advance with your team and designed to fit within your study budget.
For studies where RCC is not required or may not be feasible, WashU REDCap may be an alternative under certain conditions, described below.
WashU REDCap for Part 11 Regulated Research
REDCap is an electronic data capture (EDC) system created and maintained by Vanderbilt University, and provided at low to no cost to users, such as WashU. However, each user must configure and maintain their Institutional instance of REDCap. The Institute for Informatics Data Sciences and Biostatistics (I2DB) manages the WashU instance of REDCap (“WashU REDCap”). WashU REDCap is approved for use in WashU research studies capturing protected health information (PHI) and/or personally identifiable information (PII). WashU REDCap is maintained by I2DB, but it is a self-service EDC, and each Principal Investigator (PI) is responsible for the compliance of their project in WashU REDCap.
WashU REDCap has not yet been validated in full compliance to the Part 11 regulations. To support compliant use of WashU REDCap in certain Part 11–regulated studies, Trial-CARE and I2DB have created a Template REDCap Justification for Use (JFU) Memo. This memo documents how an unvalidated system will be used in a manner that is substantially aligned with Part 11 expectations. The REDCap JFU Memo may be used in non-commercial investigator-initiated Part 11 regulated clinical trials (e.g., drug and/or device studies with an IND and/or IDE) with lower risk to patient safety and data integrity. If you are unsure whether your study qualifies, Trial‑CARE can help you assess this.
Trial-CARE offers the following services free of cost to help you determine if your study is a good fit for the REDCap JFU Memo:
- An initial consultation to discuss your study and provide a brief overview of the REDCap JFU Memo
- Review of your study with Research Management to determine if it is a good fit for the required REDCap JFU Memo
- A follow-up consultation to onboard you to the REDCap JFU Memo and to discuss how best to tailor it to meet your study’s needs
- Review and feedback for your study’s tailored REDCap JFU Memo
Trial-CARE offers more in-depth support services and can take the lead in tailoring the REDCap JFU Memo to meet the needs of your study. We can also guide and provide training to your team so that you can effectively implement the REDCap JFU Memo in your study and take the lead in tailoring the REDCap JFU Memo for your next study. Costs apply to these services and will be scoped in advance and designed to fit into your study budget.
To learn more, please or contact Trial-CARE at TrialCare@wustl.edu or request a free 60-minute Trial-CARE consultation.
Important note: WashU REDCap is not yet Part 11–validated.
- WashU REDCap is not recommended for use in WashU investigator-initiated Part 11 regulated studies with commercial intent and/or with higher risk to patient safety or data integrity.
- Studies with commercial intent and/or higher risk to patient safety or data integrity are encouraged to utilize a validated platform, such as RCC or another system.
A member of the Trial-CARE team participated in the Clinical and Translational Sciences Award (CTSA) Working Group, “21 CFR Part 11 Compliant REDCap” contributing to the creation of the REDCap Implementation Guide for Part 11 Readiness and a peer reviewed article in the Journal of Clinical and Translational Sciences.
Frequently Asked Questions
When is alignment to Part 11 regulations required?
When a clinical trial with FDA oversight is relying upon eSignature and/or eRecords to complete submissions to the FDA – typically drug and/or device studies with a BLA, ANDA, IND, and/or IDE.
Examples:
- eSignature in clinical trials: eConsent, investigator brochure, investigator agreement, protocol signature page, FDA forms, etc.
- If using WashU DocuSign Part 11 for eSignature please see the WashU DocuSign FAQ Guidance for more information.
- eRecords in clinical trials: electronic source documentation (eSource) and electronic Case Report Forms (eCRFs) including but not limited to AE/SAE forms, analyzed data sets, etc.
- If using EPIC EHR as your source documentation, please see the WashU EPIC EHR Compliance Statement
- Submissions to the FDA: IND and IDE applications, annual reports, safety reports, and data/datasets.
Please note, electronic submissions to the FDA, such as through the CDER Next Gen Portal, CDRH portal, or Electronic Submissions Gateway Next Generation (ESG Next Gen) are expected to be handled in alignment with Part 11 regulations.
Is the system accessible for use at WashU?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| To gain access to use RCC in WashU investigator-initiated research, requests must be submitted to Trial-CARE at trialcare@wustl.edu. | WashU REDCap is accessible for use to all WashU faculty and staff and requires a WashU Key or guest WashU Key to gain access. |
Are there costs associated with the use of the system at WashU?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| Yes Costs are scoped per project. To learn more, contact Trial-CARE at TrialCare@wustl.edu. | No, not at this time although this is subject to change. However, there are optional fees for service costs (e.g., I2DB builds your REDCap project and/or configures integrations). For additional information, visit I2DB’s Informatics Core Services (ICS) for REDCap. |
Is the system validated at the system level and configured for Part 11 compliant use at WashU?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| Yes | No |
Is the WashU OIS FDA Part 11 Security Plan required?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| Yes | N/A |
Does Trial-CARE offer a support package for alignment to Part 11 regulations?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| Yes | Yes |
What package of support does Trial-CARE offer?
Please reach out to Trial-CARE for a free consultation to learn more, trialcare@wustl.edu.
What type of research studies are good use cases for the system?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| Commercial or non-commercial investigator-initiated Part 11 regulated clinical trials (e.g., BLA, ANDA, IND, and/or IDE) at all levels of risk to patient safety and data integrity. | Investigator-initiated Part 11 regulated clinical trials (e.g., IND and/or IDE studies) with lower risk to patient safety and data integrity, where there is not commercial intent attached to the study of the drug or device. |
What type of research studies are NOT recommended as use cases for the system?
| REDCap Cloud (RCC) | WashU REDCap |
|---|---|
| N/A | Any investigator-initiated Part 11 regulated clinical trials with commercial intent attached to the study of the drug or device, or with higher risk to patient safety or data integrity. |
Can you define the acronyms used when discussing REDCap Cloud and WashU REDCap for Part 11 regulated research?
RCC = REDCap Cloud
REDCap JFU Memo = WashU REDCap Justification for Use Memo
BLA = Biologics License Application
ANDA = Abbreviated New Drug Application
IND = Investigational New Drug
IDE = Investigation Drug Exemption
eSource = Electronic source
EDC = Electronic data capture
eCRFs = Electronic case report forms
Part 11 = FDA 21 CFR Part 11 Regulations
SOW = Scope of Work
SOPs = Standard Operating Procedures