mdi ConsultantsThe FDA is coming up with a new rule for existing informed consent document which is as follows:
- To require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank.
- The databank referred to in this final rule is the clinical trial registry databank maintained by the National Institutes of Health/National Library of Medicine (NIH/NLM), which was created by statute. The submission of clinical trial information to this data bank also is required by statute.
This amendment to the informed consent regulations is required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to participants and patients.
Effective date: This rule is effective March 7, 2011.
Compliance date:
The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.
Compliance date of new Sec.50.25(c) will be 1 year after the effective date of this final rule for all informed consent documents and processes related to a clinical investigation that is initiated on or after the compliance date of this rule.
IIf you plan to do a clinical trial for your drug (including biological products) and device and would like to know more on how this new rule will affect your company then please email us at info@mdiconsultants.com Ref: Informed Consent requirements.