Q: How long must an investigator retain records of a completed research study?
A: An investigator is required to retain records for a period of two years following the date of approval of a marketing application, or, if no application is to be filed or if the application is not approved for the indication being investigated, until two years after the investigation is discontinued and FDA is notified. [21 CFR 312.62(c)]
Q: How does the FDA interpret “…until two years after the investigation is discontinued and the FDA notified.”?
A: This is the date on which the sponsor discontinues all studies relevant to the investigational new drug application – not discontinuation at the investigational site. This could easily result in a study site maintaining records well beyond the 2- year period. (CDER) In addition, sponsors may require longer retention under clinical protocols. In practice, no records should be destroyed without written authorization from the sponsor.
Q: In obtaining informed consent documentation from a potential research volunteer, must the informed consent document be dated as well as signed?
A: The FDA explicitly requires that the consent form be dated as well as signed by the subject or the subject's legally authorized representative (21 CAR 50.27(a)). Also it is highly recommended, when the study procedures and informed consent occur on the same day, that the time of consent be documented.
Q: May study records be retained ‘off-site”?
A: There is no regulatory requirement that study records be maintained on-site; however, the agency does recognize the advantages of on-site storage. According to DSI, records must be maintained, must be stored under conditions that will preserve their integrity and must be accessible and retrievable in a “reasonable” time frame should such records be required for FDA inspection. Investigators are required to notify sponsors in writing regarding off-site custody of study records. FDA’s Compliance Program Guidance 73481.811
Q: What certifications are available for clinical investigators?
A: There are two certifications for clinical investigators available grouped by physician or non-physician status:
CCTI – Certified Clinical Trial Investigator—(non-physician) and
CPI – Certified Physician Investigator— (physician)
CCTI—Awarded through the Association for Clinical Research Professionals (ACRP)
From the ACRP website: A Clinical Trial Investigator, regardless of job title, works at a clinical research site as the non-physician investigator whose research activities are conducted under Good Clinical Practices (GCP), FDA regulations and ICH guidelines. For more information visit www.acrpnet.org.
The CTI Exam is a measure of the candidate's general and basic skills and knowledge of the information needed for Clinical Trial Investigators to perform effectively. Certification is granted in recognition of the applicant's documented education and working experience as a Clinical Trial Investigator and successful completion of this written exam. By granting the title of Certified Clinical Trial Investigator (CCTI™), The Academy is formally recognizing the professional Clinical Trial Investigator who has provided evidence that he or she meets those professional standards.
CPI – Awarded through Academy of Pharmaceutical Physicians and Investigators (APPI)
From the APPI website: A Physician Investigator is a physician (M.D. or equivalent degree) who serves as the primary, sub- or co-investigator or monitors, supervises, or designs clinical trials and accepts responsibility for the safe and ethical conduct of a clinical trial, herein defined as a systematic experiment designed to evaluate the pharmacokinetics, pharmacodynamics, pharmacoeconomics, safety, efficacy, and effectiveness of a drug, biological, medical device, procedure or other intervention involving human participants. For more information visit www.aapp.org. APPI offers the Certified Physician Investigator (CPI™) examination to qualified physician investigators. Certification as a CPI™ signifies that a physician possesses knowledge sufficient for the safe and ethical conduct of a clinical trial in accordance with the appropriate ethical, medical, scientific, legal, and regulatory standards. The written CPI™ examination is a measure of a candidate's general skills and knowledge of the information needed for the CPI™ to perform this role effectively.
Q: Does the University of Tennessee Health Science Center require certification for investigators?
A: Not at this time.
Q: Does 21 CFR 11 regulate the use of e-mail?
A: Though much of the information transmitted via e-mail falls outside of regulatory consideration, Part 11 is applicable to the transmission of regulatory related records required under predicate rules. Therefore, when the e-mail itself is considered a required record, such as correspondence between the IRB and investigators, the e-mail system should feature appropriate Part 11 controls, such as a trail of who created the record, a means for ensuring data integrity and a process for maintaining the record for the required regulatory retention period. [(21 CFR56.115 (a) (4)]
Q: Can confidential study information be transmitted via e-mail?
A: Under the federal regulations governing human subjects’ research and HIPAA, there is a requirement that study information and any PHI collected during the conduct of a study be protected from disclosure. Information transmitted via e-mail may or may not be protected from external or public access. At the University Health Science Center, e-mail within the “closed” network, e.g., between addresses ending with “@uthsc.edu”, is considered to be secure. Wireless connections and other internet transmissions are not considered to be secure and should be avoided unless provisions have been made between the sites to ensure security, for example, encryption.
Randall J. Nelson, Ph.D.
Professor and Associate Vice Chancellor for Research
Memphis, TN 38163
Phone: (901) 448-3533
Fax: (901) 448-5222