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Compliance In Focus
Posted by Brandy Chittester on Tue, Jul 16, 2013

Because that is how we have always done it…

Have you ever worked at a site where they follow a practice just because “that is how theyFAIR Shake I have always done it?”  At IMARC, we like to apply the FAIR Shake™ to these scenarios. What is the FAIR Shake™?

F: Federal Regulations: Describes the procedures for the conduct of clinical investigations as well as the Sponsor’s and Investigator’s responsibilities. In addition, it outlines the responsibilities of the IRB, the requirements for informed consent and financial disclosure.

A: Agreements: Statement of the investigator’s commitment to conduct the study in compliance with the regulations, protocol and IRB; Supervision of the investigational product; and obtain informed consent. The Agreement can include other items agreed upon with the Sponsor.

I: Investigational Plan: The protocol! Includes inclusion/exclusion, procedural and follow-up requirements, and adverse event definitions.

R: Requirements of the IRB: Includes informed consent process, requirements for adverse event and protocol deviation reporting, renewal timelines.

Why FAIR?  21 CFR 312.50 and 312.60; 21 CFR 812.40 and 812.100.  FAIR was derived from the general responsibilities of sponsors and investigators in clinical investigations listed in 21 CFR 312 and 812. It is important to follow FAIR to have a solid regulatory basis for decisions that are made in the clinical research setting.

If it doesn’t fall into one of the categories above, is it necessary?

  • Scenario 1: We must complete all source worksheets and CRFs in black ink, blue ink is not allowed. Why? Because “we have always done it that way.”
    • Let’s apply FAIR Shake™ to this theory. Must the site only use black ink?
      • There is definitely nothing in (F): Federal Regulations that mandate what color ink must be used. It is also highly unlikely that ink color would be specified in the (A): Agreement, (I): Investigational Plan or (R): A requirement of the IRB.
  •   Scenario 2: We must place a stamp of “COPY” on all printed electronic medical record source. Why? Because “we have always done it that way.”
    • Again, let’s apply FAIR Shake™. Is it a requirement that the site place a stamp of “COPY” on all printed documents?
      • (F): Federal Regulations- 21 CFR 812.140 states that an investigator shall maintain accurate, complete and current records of each subject’s case history including the case report forms and supporting data, for example, medical records including progress notes of the physician, the individual’s hospital chart and nurses’ notes. So, it is not a federal regulation to stamp “COPY” on printed medical records. Again, it is also highly unlikely to be mentioned in the (A): Agreement, (I): Investigational Plan or (R): A requirement of the IRB.
  • Scenario 3: After the subject and the person obtaining consent have signed the informed consent document the Principal Investigator must sign the document too. Why? Because “we have always done it that way.”
    • Let’s give it a Shake
      • (F): Federal Regulation-21 CFR 50.27 (a) only says that informed consent should be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or legally authorized representative. It doesn’t mention anything about the person obtaining consent or the PI signing. It is highly unlikely that it would be a requirement in the (A): Agreement or (I): Investigational Plan. However, it may be (R): A requirement of the IRB.

Just because that is how you have always done it, does not mean that it is a requirement.

However, there is always an exception to the rule! A site’s SOP may state they have to use only black ink or the PI must sign the ICF. If this is the case, it would be a requirement. The site must follow their own SOP (although this may not be a finding in a regulatory inspection).

In the future, you should give your study a FAIR Shake™.  For more information about FAIR Shake ™, check out our whitepaper!

Do you have any examples to share?

Photo Credit:Leo Reynolds

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Topics: FAIR Shake™, 21 CFR 312.50, 21 CFR 812.40, IMARC Research


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