Tip of the Month
Monthly research compliance reminders and information.
Explore our Tip of the Month Archive below.
August 2026
Delegation of Authority 
A well-maintained Delegation of Authority (DOA) log is an essential study document that demonstrates who is authorized to perform study related tasks and helps ensure compliance with Good Clinical Practice (GCP). See reminders below to help keep your DOA log in tip top shape!
List Roles for Every
Team Member
Every individual listed on the DOA log should have their study role clearly identified (e.g., Principal Investigator, Sub Investigator, Regulatory Coordinator, etc.). Roles should accurately reflect each person's responsibilities.
Document Delegated
Tasks
The DOA log should clearly document the study-specific tasks each individual is authorized to perform. Review the log periodically to ensure delegated responsibilities remain accurate as personnel or responsibilities change.
Who to List on the
DOA log
Personnel performing routine procedures within their licensed scope of practice (e.g., phlebotomists, laboratory personnel, ultrasound technicians) generally do not need to be listed on the Delegation of Authority (DOA) log. Study team members should only be delegated tasks that are within their training, qualifications, and scope of practice.
PI Oversight
The PI is ultimately responsible for oversight of study conduct and delegated responsibilities. As a best practice, the PI should review/initial next to each individual entry on the DOA log to document acknowledgment and approval of study personnel.
Quick DOA Checklist
Take a moment to quickly review your DOA log to ensure it includes:
- All study personnel performing study specific tasks
- A clearly documented role for every individual
- Appropriately documented responsibilities for each team member
- Start and end dates, where applicable
- PI initials next to each individual entry
July 2026
Summary of Changes
ICH E6(R2) |
ICH E6(R3) |
|
Traditional site-based trials |
Supports modern trial models Explicitly accommodates remote visits, eConsent, and digital health technologies. |
| Compliance-focused Emphasis on following procedures and maintaining documentation. |
Quality-focused Emphasis on designing studies that prevent issues before they occur. |
| Risk-based monitoring introduced Monitoring could focus on higher-risk areas. |
Risk-based quality throughout Risk assessment is expected from study design through study closeout. |
| Limited direction on digital tools Organizations often interpreted how GCP applied to new technologies. |
Digital tools addressed directly Provides clearer expectations for wearables, ePROs, and electronic systems. |
| Role-based guidance Requirements organized around sponsors, investigators, and monitors. |
Principle-based guidance Applies the same GCP principles across a wider variety of trial types. |
| Data review often broad Many activities received the same level of oversight. |
Focus on what's critical Oversight should prioritize participant safety and key study data. |
ICH E6(R3) is not just an update—it is a modernization of Good Clinical Practice. While the core principles of participant protection and data integrity remain unchanged, R3 shifts the focus from prescriptive compliance to a more flexible, risk-based, and quality-driven approach that better supports modern clinical research.
References:
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_St ep4_FinalGuideline_2025_0106.pdf?utm_source=chatgpt.com
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-gcp?utm_source=chatgpt.com
June 2026
Prior and Concomitant Medication
Current and prior medications should be documented and reviewed by the Principal Investigator (PI) or delegated Sub-Investigator (Sub-I) prior to enrollment and administration of study intervention.
Documentation should be maintained for the duration of the study to prevent potential interactions with study intervention.
Source Documentation
It is recommended to record all concomitant medications and treatments on a running log for each study participant. Prescription medications, over the counter (OTC) medications, dietary supplements, vitamins, and topical medications should be documented. Each concomitant medication should have a corresponding Medical History condition or Adverse Event (AE).
Protocol Review
The current approved IRB protocol within ERICA should be reviewed to confirm the specified time windows for documenting prior medications, required washout periods, and any medications that may constitute eligibility exclusions.
Identification
Concomitant medications and treatments may be identified through medical records, patient report, procedure notes, and AE reports (medications/treatment given for AE’s and procedures should be documented).
Tracking Specifications
Multiple entries may occur for the same medication if there are changes in dosage or the study participant stops and restarts the medication.
May 2026
Is Your Study a Clinical Trial, a Basic Experimental Study Involving Humans (BESH), or an Observational study?
Accurate classification of a research study is critical for ensuring compliance with reporting requirements. Classification of a research study includes the following:
Clinical Trial
Involves assigning human participants to an intervention (e.g., drug, behavior change, or environmental exposure) to evaluate its effect on a health-related outcome.
Basic Experimental Studies with
Humans (BESH)
Focuses on understanding fundamental biological or behavioral processes without a direct health outcome goal.
*Effective for completing applications submitted for due dates on or after May 25, 2026, the NIH will no longer characterize BESH as clinical trials and will no longer be subject to NIH clinical trial requirements. For applications submitted for due date on or before May 24, 2026, BESH will continue to be treated as a clinical trial.
See NIH notice NOT-OD-26-027 for more information and guidance.
Observational Studies
Researchers do not intervene - data is only collected or analyzed (prospectively or retrospectively). These include natural history, secondary data, and repository studies. These are not clinical trials or BESH.
The table below can help determine research study classification
|
Human Participants? |
Prospective Assigned Intervention? |
Evaluate Effect of Intervention? |
Health-Related Outcome? |
Study Type |
|
Yes |
Yes |
Yes |
Yes |
Clinical Trial |
|
Yes |
Yes |
Yes |
No |
BESH |
|
Yes |
Yes |
No |
No |
Observational |
|
Yes |
No |
No |
Yes |
Observational |
|
Yes |
No |
No |
No |
Observational |
April 2026
Voluntary Participation
Voluntary participation is a fundamental element of conducting ethical research and should be respected throughout the entire research process.
Key Aspects Include:
Informed Consent: Participants should understand the research study's purpose, risks, and procedures
before agreeing to take part.
Participants must be informed of new information that may affect their willingness
to continue.
Freedom to Withdraw: Participants can stop study participation at any time without negative repercussions, such as losing services or benefits.
Protection of Vulnerable Group: Special care is required to ensure that individuals with diminished capacity or in dependent relationships do not feel pressured to participate.
Absence of Coercion: Researchers must not use pressure, manipulation, or excessive undue incentives to force participation.
Respect for Autonomy: If a potential participant declines participation, additional recruitment attempts should not occur. Repeated approaches (email, phone, in-person) may undermine voluntary participation.
March 2026
Obtaining Adverse Events (AEs)
An adverse event is any untoward medical occurrence (or worsening of an existing condition) in research participants, which may or may not have a causal relationship with the study treatment.
When obtaining AEs from research participants several methods may be used to collect AEs. It is recommended to review all applicable methods and document identified AEs on an AE log.
Recommended Methods
Review of medical records, including physician and nurses' progress notes, procedure notes, and outside medical records.
Lab and test results deemed clinically significant should be assessed for potential AEs and if applicable, added to the participant's medical history.
Common FDA findings include failure to report or not adequately record AEs.
Upcoming event
FDA Inspections: Institutional Experiences
Tuesday, April 21, 2026 2:00pm
Join the Research Quality Compliance Network for a panel discussion featuring institutional leaders who will share practical insights and lessons learned from FDA inspections. This session will provide valuable perspective for research teams preparing for or navigating regulatory review.
February 2026
Documenting Eligibility
Eligibility should be reviewed and documented by the study coordinator and Principal Investigator (PI) or delegated Sub-Investigator (Sub-I), PRIOR to enrollment, and randomization. The following documentation practices are recommended:
Signature of the investigator to confirm eligibility criteria should ONLY be done after all eligibility criteria are confirmed. There should be no criterion pending prior to enrollment and randomization.
For therapeutic studies, all screening labs and/or imaging and diagnostic reports MUST be documented as reviewed by the PI or delegated Sub-I prior to enrollment and randomization.