Project Planning & Execution Flashcards

At study closeout, which action must be completed BEFORE destroying any study records?

Answer: Obtaining final IRB closure approval and confirming the regulatory retention period has elapsed

Records cannot be destroyed until the IRB has formally closed the study and the required retention period (often 7–15 years) has elapsed per regulatory requirements.

A PI is closing out a NIH grant. The final Federal Financial Report (FFR) must be submitted within how many days of the project period end date?

Answer: 90 days

NIH requires the final FFR (SF-425) to be submitted within 120 days of the project period end date through the Payment Management System.

Which of the following BEST describes 'scope creep' in the context of research project management?

Answer: Gradual, uncontrolled expansion of project objectives beyond original IRB-approved aims

Scope creep is the unplanned and uncontrolled expansion of a project's objectives, which can strain resources, timelines, and regulatory compliance.

A PI must ensure that all team members complete required human subjects training. This requirement stems primarily from:

Answer: The Common Rule (45 CFR 46) and federal funding agency requirements

The Common Rule and federal funding agencies (NIH, NSF) mandate that all personnel involved in human subjects research complete appropriate ethics training.

During project execution, a stakeholder requests a major change to the primary endpoint. The FIRST step the PI should take is to:

Answer: Assess the impact on the IRB protocol, statistical plan, and regulatory submissions before acting

Any major protocol change must be evaluated for its impact on ethics approval, statistical power, and regulatory submissions before implementation.

A PI is responsible for ensuring that all financial conflicts of interest (FCOI) related to the research are disclosed to which entity?

Answer: The institution's designated official and ultimately the federal funding agency

Under 42 CFR 50 Subpart F, investigators must disclose significant financial interests to their institution, which in turn reports management plans to the federal funding agency.

Which closeout activity ensures that future researchers can build upon the completed study's findings?

Answer: Archiving de-identified datasets in a publicly accessible repository per the data sharing plan

Depositing de-identified data in a public repository fulfills NIH data sharing requirements and enables replication and meta-analysis by the broader research community.