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Compliance In Focus
Posted by Shawn Kennedy on Mon, Dec 16, 2013

On the Twelfth day of Clinical Research…The FDA gave to me…

If you work in clinical research, chances are you are familiar with the FDA regulations (21 CFROn the twelfth day of Christimas and all of its parts). If you’re like me though, you may have a strong understanding of these regulations but still need to reference a regulatory book from time to time if you want to be sure or cite something. Well IMARC’s present to you this year is a quick reference guide for regulatory time requirements for Investigators and Sponsors of medical device research, as well as IRBs. For space sake, we are paraphrasing. Please don’t feel obligated to get us any gifts in return. You can give the gift of human subject protection to every research subject involved simply by striving to meet these requirements.

IRBs
Timeline Item Regulation
30 Days 30 days Report changes in types of research reviewed or discontinuation as an IRB (notify registrar) 21 CFR 56.106(e)
90 Days 90 days Update contact person or chair information changes (notify registrar) 21 CFR 56.106(e)
At least annually Conduct continuing review of research being overseen 21 CFR 56.109(f)
3 years Renew registration 21 CFR 56.106(c)
3 years Maintain records 21 CFR 56.115(b)
Investigators
Timeline Item Regulation
5 working days Withdrawal of IRB approval (notify sponsor) 21 CFR 812.150(a)(2)
5 working days Emergency use (notify sponsor and IRB) 21 CFR 812.150(a)(4)
5 working days Device use without obtaining consent (notify sponsor and IRB) 21 CFR 812.150(a)(5)
10 working days UADE (notify sponsor and IRB) 21 CFR 812.150(a)(1)
3 months Final report (notify sponsor and IRB) 21 CFR 812.150(a)(6)
At least annually Submit progress report (notify sponsor, monitor, and IRB) 21 CFR 812.150(a)(3)
1 year Financial disclosure (notify sponsor up to 1 year after) 21 CFR 812.110(d)
2 years Maintain records 21 CFR 812.140(d)
Sponsors
Timeline Item Regulation
Within 5 working days Developmental changes and changes to the clinical protocol that don’t affect the validity of the data, scientific soundness of the investigational plan, or rights, safety, or welfare of human subjects (notify FDA) 21 CFR 812.35(a)(3)
5 working days Emergency use (notify FDA) 21 CFR 812.35(a)(2)
5 working days Withdrawal of IRB approval (notify FDA and IRBs) 21 CFR 812.150(a)(2)
5 working days Withdrawal of FDA approval (notify investigators and IRBs) 21 CFR 812.150(b)(3)
5 working days Device use without obtaining consent by investigator (notify FDA) 21 CFR 812.150(b)(8)
5 working days Significant risk determination made by an IRB (notify FDA) 21 CFR 812.150(b)(9)
5 working days/15 working days Termination of an investigation (5 working days of determining an UADE presents an unreasonable risk to subjects, and 15 working days from first receiving notice) (notify FDA) 21 CFR 812.46(b)(2)
10 working days Transfer of records custody (notify FDA) 21 CFR 812.140(e)
10 working days Transfer of records custody (notify FDA) 21 CFR 812.140(e)
10 working days UADE (notify FDA and IRBs) 21 CFR 812.150(b)(1)
30 working days 30 working days Request that an investigator return, repair, or otherwise dispose of any units of a device (notify FDA and IRBs) 21 CFR 812.150(b)(6)
30 working days Final report (notify FDA) 21 CFR 812.150(b)(7)
30 working days/td> Wait to conduct an IDE until FDA approval is granted 21 CFR 812.20(a)(4)(i)
30 working days Treatment use 21 CFR 812.36(c)(2)(d)
6 months Current investigator list (notify FDA) 21 CFR 812.150(b)(4)
  Final report (notify investigators and IRBs) 21 CFR 812.150(b)(7)
At least annually Annual progress report (notify FDA and IRBs) 21 CFR 812.150(b)(5)
1 year 1 year Financial disclosure from investigators (notify FDA up to 1 year after) 21 CFR 812.43(c)(5)
2 years Maintain records 21 CFR 812.140(d)

Topics: FDA Regulations, Sponsors, IRB

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