GCP and Oversight
This party has ultimate responsibility for the conduct of a clinical trial at the site, even when tasks are delegated.
Who is the Principal Investigator?
Consent must occur before this happens.
What is any study-specific procedure?
ALCOA stands for these five qualities.
What are Attributable, Legible, Contemporaneous, Original, and Accurate?
This term describes any unfavorable medical occurrence in a subject, whether or not related to the investigational product.
What is an adverse event?
These files collectively demonstrate that the investigator, sponsor, and site complied with GCP and applicable requirements.
What are essential documents / the regulatory binder?
This GCP concept means duties may be delegated, but accountability cannot be transferred.
What is investigator responsibility / PI oversight?
This is the ongoing process of giving subjects information and opportunity to ask questions, not merely getting a signature.
What is informed consent?
This principle is violated when a coordinator fills in visit details from memory days later without explanation.
What is contemporaneous documentation?
This term describes an AE that results in death, is life-threatening, requires hospitalization, causes disability, or meets other serious criteria.
What is a serious adverse event?
This approval should be documented before enrolling subjects under a new protocol version.
What is IRB approval?
This type of oversight focuses on preventing important errors before they affect subject safety or data reliability, rather than catching every minor issue afterward.
What is risk-based oversight?
A new risk is discovered that may affect willingness to continue participation. This is generally required.
What is re-consent or notification through an IRB-approved consent update?
A correction that hides the original entry violates this data integrity expectation.
What is Attributable, Legible
A protocol-required physical exam is skipped during a telehealth visit. The monitor says it is “fine,” but the protocol was not followed. This should usually be documented as this.
What is a protocol deviation?
This essential document shows the IRB-approved language a participant agreed to at the time consent was obtained, including the correct version date.
What is the signed informed consent form?
This document should show who was authorized to perform study procedures, when authorization began, and when it ended.
What is the Delegation of Authority Log?
A subject signs an outdated consent form after a new version has been IRB-approved and activated. This is this type of problem.
What is use of an incorrect or expired consent version?
This is the regulatory problem when the EDC says a procedure was done, but there is no source documentation supporting it.
What is lack of source support / unverifiable data?
This is the key distinction between an AE and a protocol deviation.
What is subject medical event versus failure to follow the protocol?
A delegated sub-investigator is missing a current CV, medical license, or credentials file. This creates a documentation gap showing that the person had this required status.
What is documented qualification to perform study duties?
A PI signs a Form FDA 1572 but never personally reviews enrollment, safety, or protocol conduct. This creates this major inspection concern.
What is inadequate investigator oversight?
This error can invalidate consent even if the form is signed and dated correctly.
What is failure to provide adequate opportunity for understanding or voluntary decision-making?
ICH E6 uses this term for the documents that individually and collectively permit evaluation of study conduct and the quality of the data produced.
What are essential documents?
A hospitalization is missed because the subject went to an outside hospital and no one reviewed outside records. This most directly reflects a weakness in this process.
What is adverse event surveillance / safety follow-up?
This document confirms that the sponsor and investigator agreed on the final protocol and any amendments before conducting the study under those requirements.
What is the signed protocol signature page