Documentation
Information such as participants’ name, address, date of birth, or other identifiers
What is PHI?
A single strikethrough with initials and date
What is a proper correction?
Application needed to conduct research on products not approved by the FDA
What is an IND?
Documents stored in participant binders with subject IDs only
What are de-identified source documents?
Report due each year on anniversary of IRB approval
What is an IRB Continuing Review?
Approved, stamped document that’s pulled from eIRB and signed by participant, witness, and/or provider
What is the informed consent form?
Ways to fill in missing or blank spaces or fields on source documents
What is MS, N/A, or unknown?
What is FDA Form 1571?
Document that explains a discrepancy, missing data, AE or PD, or another out of the ordinary or otherwise unexplained deviation – must include signature and date
What is a note to file?
The only color pen that should be used when completing study documents.
What is black ink?
The date a study team member is approved to be added to the study team list in the eIRB
What is the DOA start date?
Anything done out of order, if a participant does the wrong task, or any issues with dosing (i.e participant is given the wrong dose or dosed at the wrong time).
What is a protocol deviation?
Documentation needed for PIs and sub-investigators listed on the 1572
What are CVs, licensure, and training certificates?
This section of the Study Notebook should include a note to file specifying where the raw and electronic data for this study can be found (e.g., participant binder, OneDrive, USB drive, etc.)
What are Data Locations?
Name, responsibilities, initials, signature, start date, end date, PI initials
What are required elements of the Delegation of Authority log?
Addressing missing signatures on eligibility checklists
What is having the PI sign ASAP and writing a note to file?
This is why we care about good documentation, following GCP guidelines, and minimizing discrepancies.
What is the assurance that data are credible and accurate?
Communication to the FDA required each year – bonus for including required documents for submission
What is an IND annual report?
Bonus: Cover letter, FDA Form 1571, report
This section of the Regulatory Binder contains the IRB roster, initial application, CIR approvals, continuing reviews, and protocol events.
What are IRB Materials?
Group that monitors study progress and data integrity
Hint: NOT the DSMP – which is the monitoring plan
What is the DSMB – data safety monitoring board?