Georgetown Research Services
Georgetown Research Services

Training and Education

All study team members involved in human subjects research must complete Human Subjects Protection (HSP) training. This training ensures that researchers understand the ethical principles and regulations for protecting research participants.

To meet this requirement, complete the appropriate HSP course based on the type of research being conducted.

For detailed instructions and access to the training link, click here.

The Clinical Research Coordinator Seminar Series is held once a month on the first Wednesday of each month from 12:30pm – 2:00pm ET. This series is designed for Clinical Research Professionals and other vested in the care of research participants. The series provides opportunities for professional development as well as updates on GU policies, procedures and operations related to clinical research.

Registration for the monthly CRCSS meeting: Add this event to your calendar

Our Summer Education and Training Series was held on Mondays from 1-2pm July 15-August 26, 2024. Topics covered included:

  • Informed Consent Process and Documentation
  • Non-English Speaking Participants ICF process
  • Source Documentation
  • AE/Safety Monitoring Documentation
  • RNI Reporting
  • IP Management and Accountability 
  • Audit Preparation – FDA/other external audits

Recording and Slide Presentations

Guidance for use of 21 CFR Part 11 Compliant Systems

What is 21 CFR Part 11?

The way clinical trials are conducted has necessitated the use of electronic systems, records, and signatures.  The use of electronic systems has not changed the requirement for trial results to be reliable, reproducible and accurate; therefore, it is essential to ensure the integrity and security of the electronic data generated in the course of a clinical trial.  The FDA’s Code of Federal Regulations (CFR), specifically 21 CFR Part 11, has outlined criteria for considering electronic records, electronic signatures:

  • trustworthy
  • reliable
  • equivalent to paper records and handwritten signatures executed on paper

In addition to the CFR, the FDA has provided guidance documents to assist institutions and study teams understand how to apply these criteria. 

When does it apply?

This regulation applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any FDA regulation for records requirements including predicate regulations.  

  • If you are conducting an FDA-regulated study and you are utilizing either electronic records or electronic signatures, you are obligated to maintain 21 CFR Part 11 compliance.
  • If you are conducting research that is not FDA-regulated, you are not required to follow 21 CFR Part 11 compliance at this time.

What does FDA-Regulated mean?

FDA regulated means the study involves clinical trials with drugs or devices as well as studies directly funded or supported by the FDA.

What are predicated rules?

Any FDA regulation that requires certain records to be maintained or submitted to the FDA.

For example:

GxP is a general term to refer to FDA’s regulations governing:

  • Good Clinical Practice (GCP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)

The GxP regulations are the Predicate Rules that describe FDA’s requirements for the conduct of research performed under these regulations.  If the Predicate Rules require certain records to be maintained or submitted to the FDA, and these records are in electronic format, then 21 CFR 11 applies.

For example:

FDA’s regulation 21 CFR 50.27: Documentation of Informed Consent, is a Predicate Rule, which states the following:

“… informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form…”

If a researcher conducting an FDA-regulated study wants to document a subject’s informed consent by obtaining an electronic signature and date from a subject or subject’s legally authorized representative, then the electronic system used to capture the electronic signature and date must meet the requirements of 21 CFR Part 11.

What electronic records require 21 CFR Part 11 Compliance?

21 CFR Part 11 Compliance applies to records needed for FDA to reconstruct a clinical investigation that are maintained and archived under any of the FDA rules (predicate rules) in electronic format in place of paper format or where the electronic record is relied on to perform regulated activities. Additionally, records submitted to FDA in electronic format under any of the FDA rules (predicate rules), even if such records are not specifically identified in FDA regulations.

Specific examples of Clinical Trial Documents that fall under Part 11 include:

  • FDA Form 1572
  • Delegation of Authority Logs
  • Training Logs
  • Consent / Assent / HIPAA (see Guidance on Remote and eConsent)
  • Protocol Signature Pages
  • Investigator Brochure Signature Pages
  • Sponsor Acknowledgement Forms
  • Sponsor Conflict of Interest / Financial Disclosure Forms
  • Any Documents specified by sponsor policy

How do I obtain a 21 CFR Part 11 Docusign Account and complete the required training?

  • For a research account that requires use of 21 CFR Part 11, be sure to select “Yes” to the “Do you participate in FDA-regulated clinical research?” question and describe how you intend to use Docusign in the following question.
  • You must complete the required 21 CFR Part 11 Docusign online training  before your account will be granted. There are four sections, each with a review quiz. You must score a 100% on all four quizzes. There is no limit to the number of retakes.

The On-Line Collaborative Research Environment (OnCore) is a comprehensive web-based suite of research modules that integrates all of the components of research activity administered by MedStar Health facilities, all affiliated and satellite locations, MedStar Georgetown University Hospital, and Georgetown University Medical Center. The system is designed to serve the needs of research teams, departments and support the continued strengthening of standards for efficiency, safety, quality, and compliance. More information regarding OnCore can be found on the OnCore™ Clinical Trial Management System page.

OnCore training: Please contact Tessa Impallaria (Tessa.A.Impallaria@medstar.net) to register for a training session.