For applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on
www.ClinicalTrials.gov.
Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials. IRBs cannot modify or delete the exact statement regarding www.ClinicalTrials.gov as stated in 21 CFR § 50.25(c).
“A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
An “applicable clinical device trial”:
(I) the trial prospectively compares a device-based intervention subject to FDA regulation against a control in human subjects; or (II) the trial is a pediatric post-market surveillance trial. 42 U.S.C. § 282(j)(1)(A)(ii).
An “applicable clinical drug trial”:
The trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to FDA regulation. 42 U.S.C. § 282(j)(1)(A)(iii)(I).
Clinical trials are specifically excluded from the definition of “applicable clinical trials”:
For devices, small feasibility trials and larger clinical trials of prototype devices with a primary measure of feasibility rather than health outcomes are not applicable clinical trials. 42 U.S.C. § 282(j)(1)(A)(ii). Under current guidance contained on NIH’s website at http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf, a device trial is not an applicable device clinical trial when the trial includes only de-identified human specimens and does not include “human subjects” (a requirement to be considered an applicable clinical trial).
For drugs, phase 1 clinical investigations (defined in 21 C.F.R. § 312.21) are not categorized as “applicable clinical trials.” 42 U.S.C. § 282(j)(1)(A)(iii). Uncontrolled clinical investigations of drugs or devices also are not considered “applicable clinical trials.”
Original document can be found from the link below:
Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c), Fab., 2012
Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials. IRBs cannot modify or delete the exact statement regarding www.ClinicalTrials.gov as stated in 21 CFR § 50.25(c).
“A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”
An “applicable clinical device trial”:
(I) the trial prospectively compares a device-based intervention subject to FDA regulation against a control in human subjects; or (II) the trial is a pediatric post-market surveillance trial. 42 U.S.C. § 282(j)(1)(A)(ii).
An “applicable clinical drug trial”:
The trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to FDA regulation. 42 U.S.C. § 282(j)(1)(A)(iii)(I).
Clinical trials are specifically excluded from the definition of “applicable clinical trials”:
For devices, small feasibility trials and larger clinical trials of prototype devices with a primary measure of feasibility rather than health outcomes are not applicable clinical trials. 42 U.S.C. § 282(j)(1)(A)(ii). Under current guidance contained on NIH’s website at http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf, a device trial is not an applicable device clinical trial when the trial includes only de-identified human specimens and does not include “human subjects” (a requirement to be considered an applicable clinical trial).
For drugs, phase 1 clinical investigations (defined in 21 C.F.R. § 312.21) are not categorized as “applicable clinical trials.” 42 U.S.C. § 282(j)(1)(A)(iii). Uncontrolled clinical investigations of drugs or devices also are not considered “applicable clinical trials.”
Original document can be found from the link below:
Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c), Fab., 2012
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