ClinicalTrials.gov. Presented by: Suzanne O’Shea Baker & Daniels LLP 317-569-4649 [email protected] Clinical Trial Databases. Food and Drug Administration Amendments Act enacted September 27, 2007 Expanded database includes drugs and devices Nearly all clinical trials
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42 U.S.C. 282(j)(1)(A)(ix)
May be designated as responsible party by sponsor, grantee, contractor or awardee when:
Be sure to determine if YOU are the Responsible Party for your trial!
(d) Investigator means an individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or in the event of an investigation conducted by a team of individuals, is the responsible leader of that team.
(e) Sponsor means a person who initiates a clinical investigation, but who does not actually conduct the investigation, i.e., the test article is administered or dispensed to or used involving, a subject under the immediate direction of another individual.
(f) Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., corporation or agency.
Purpose: to enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials.
Information must be submitted to www.clinicaltrials.gov within 21 days after the first patient is enrolled. 42 U.S.C. § 282(j)(2)(C)(ii)
42 U.S.C. § 282(j)(2)(C)
Now includes drug and device trials.
Previously, only trials of drugs for serious or life threatening diseases or conditions were required to register.
42 U.S.C. 282(j)(1)(A)(i)
42 U.S.C. § 282(j)(1)(A)(ii)
42 U.S.C. § 282(j)(1)(A)(iii)
42 U.S.C. § 282(j)(5)(B)
see also slide 31
Responsible party for a trial that is:
May submit complete clinical trial information as long as all required information is submitted.
42 U.S.C. § 282(j)(4)(A)
NIH encourages registration of ALL trials
whether or not required by law.
NIH notice number: NOT-OD-08-014
Note: ICMJE recently adopted a recent expanded definition of “clinical trial” to include essentially all clinical trials, including Phase I trials, but excluding purely observational studies.
Under this expanded definition, if your trial begins enrollment on or after July 1, 2008, an ICMJE journal will consider it for publication only if it is registered.
21 U.S.C. § 505(i)(4)
42 U.S.C. § 282(j)(4)(C)(i)
With the exception of recruitment status, individual site status, location, and contact information, updates to registration will not result in removal of information from the data base.
42 U.S.C. § 282(j)(4)(C)(ii)
The term ‘completion date’ means the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome…..
42 U.S.C. § 282(j)(1)(A)(v)
42 U.S.C. § 282(j)(2)(A)(ii)
42 U.S.C. § 282(j)(2)(B)(i)
42 U.S.C. § 282(j)(3)(E)(i)
42 U.S.C. § 282(j)(3)(E)(iii), (iv), (v), and (vi)
Upon written request from responsible party, the Secretary may waive the requirement that results information be submitted if:
Within 30 days of any waiver, the Secretary must notify the appropriate Congressional committee of the waiver and provide an explanation for why the waiver was granted.
42 U.S.C. § 282(j)((3)(H)
42 U.S.C. § 282(j)(3)(C)
42 U.S.C. § 282(j)(3)(D)
42 U.S.C. § 282(j)(3)(D)(iii) and (vii)
42 U.S.C. § 282(j)(3)(I)
When necessary to protect the public health, the Secretary may require registration and results information about:
42 U.S.C. § 282(j)(4) (B)
42 U.S.C. 282(j)(5)(A)
If responsible party fails to submit required registration or results information, Director of NIH shall include in the database a statement that responsible party is not in compliance for:
Database will be searchable on such notices
42 U.S.C. § 282(j)(5)(E)
Certification that all database requirements have been fulfilled required in:
42 U.S.C. § 282(j)(5)(B)
21 U.S.C. § 331(jj)(1)
Civil Money Penalties
Any person who commits a prohibited act is subject to a civil money penalty of not more than $10,000 for all violations adjudicated in a single proceeding.
If violation is not corrected within 30 days, responsible party may be subject to a civil money penalty of not more than $10,000 for each day violation is not corrected.
21 U.S.C. § 331(jj)(2)