AAHRPP Evaluation Instrument (2018-10-15)

ELEMENT III.2.D.

REQUIRED WRITTEN MATERIALS

sponsor and the IRB or EC with any additional (vi) If the IRB or EC terminates or suspends approval
requested information (e.g., autopsy reports and of the clinical trial, the researcher promptly notifies
terminal medical reports). the sponsor.
(iv) The researcher provides written reports to the
sponsor, the IRB or EC, and, where applicable, the (vii) U pon completion of the clinical trial, the research-
organization on any changes significantly affect- er informs the organization; the IRB or EC with a
ing the conduct of the clinical trial or increasing the summary of the trial’s outcome; and the regulatory
risk to participants. authority with any reports required.
(v) I f the researcher terminates or suspends a clinical
trial without prior agreement of the sponsor, the
researcher informs the organization, sponsor, and
the IRB or EC.

OUTCOMES

• R esearchers and research staff follow reporting require-
ments for research studies, including reporting:

• Events, incidents, and problems according to the orga-
nization’s policy on unanticipated problems involving
risks to participants or others.

• Non-compliance.
• Suspensions or terminations of research.
• Complaints.
• Protocol deviations and violations.
• Data and safety monitoring reports.
• Other required information.

Element III.2.D. 251

GLOSSARY

GLOSSARY OF ACRONYMS

DHHS Department of Health and Human Services
DoD Department of Defense
DoDD Department of Defense Directive
DOE Department of Energy
DOJ Department of Justice
EC Ethics Committee
ED Department of Education
EPA Environmental Protection Agency
FDA Food & Drug Administration
FERPA Family Educational Right and Privacy Act
GCP Good Clinical Practice
HRPP Human Research Protection Program
ICH-GCP International Committee on Harmonisation – Good Clinical Practice
IDE Investigational Device Exemption
IND Investigational New Drug
IRB Institutional Review Board
NIJ National Institute of Justice
NNSA DOE’s National Nuclear Security Administration
NSF National Science Foundation
OHRP Office for Human Research Protection
ORE Office of Research and Evaluation
ORO Office of Research Oversight
PHS Public Health Service
SAE Serious Adverse Effect
VA Department of Veterans Affairs

Glossary of Acronyms 253