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HRPP Policy - ClinicalTrials.gov Compliance
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Quality Improvement Office (QIO)
1.0 - Scope
This policy applies to human subjects research conducted by IU researchers. This includes IU research under the oversight of the IU IRBs and research for which IU is relying on an external IRB for oversight.Back to top
Applicable clinical trials (ACTs) and NIH-funded clinical trials for which the IU PI is designated as the Responsible Party must be registered on ClinicalTrials.gov.
Information necessary to register these trials on ClinicalTrials.gov must be submitted to ClinicalTrials.gov not later than 21 days after the first subject is consented for participation.
The content of the registration must be consistent with the IRB-approved protocol.
When a research study is not required to register on ClinicalTrials.gov as described in section 2.1, its registration on ClinicalTrials.gov is considered voluntary.
The content of voluntary registrations must be consistent with the IRB-approved protocol.
Voluntary registration of FDA-regulated trials which do not meet the requirements for mandatory registration does subject the trial to the additional requirements described below for record maintenance.
Study records for FDA-regulated trials which are active on ClinicalTrials.gov must be reviewed in their entirety to verify accuracy of the record at least once every 12 months.
Additionally, the following information must be updated in ClinicalTrials.gov within 30 calendar days of the change:
- Study Start Date
- Overall Recruitment Status
- Individual Site Status
- Human Subjects Protection Review Board Status
- Primary Completion Date
- Study Completion Date
- Responsible Party name and contact information
- Any change in the study communicated to study participants and which also constitutes a change to information in the ClinicalTrials.gov record
See 42 CFR 11.64 for additional information regarding required updates for FDA-regulated trials.
For trials which are required to register on ClinicalTrials.gov as described in section 2.1, results information must be submitted for posting on ClinicalTrials.gov.
Primary results must be posted on ClinicalTrials.gov no later than one year after the Primary Completion Date as listed in the ClinicalTrials.gov study record unless an extension is granted by ClinicalTrials.gov. Additional results must be posted no later than one year after the Study Completion Date unless an extension is granted by ClinicalTrials.gov.
For ACTs and voluntary registrations of FDA-regulated studies, the Responsible Party is the trial’s sponsor or sponsor-investigator, as such terms are defined by the FDA.
For non-FDA-regulated NIH-funded clinical trials, the Responsible Party is the prime awardee.
Where IU would be considered the Responsible Party under the above definitions, the IU principal investigator (PI) is designated as the Responsible Party.
For voluntary registrations, the Responsible Party is the IU PI.
Registration and results reporting are completed by the Responsible Party or designee via the ClinicalTrials.gov Protocol Registration and Results System (PRS). IU researchers may request a user account for the IU PRS account by contacting email@example.com.
Each time a record is created or modified in PRS, the revisions must be approved and released in ClinicalTrials.gov by the Responsible Party.
The IU Quality Improvement Office (QIO) performs routine quality reviews of ClinicalTrials.gov records in the IU PRS account to identify errors in registration, problems with record maintenance, and to alert investigators of upcoming results submission deadlines.
QIO staff review IU HRPP records of new study submissions to identify studies requiring mandatory registration as described in section 2.1. If such studies are not yet registered on ClinicalTrials.gov, QIO staff will notify the PI regarding the need for registration. If the PI disagrees with QIO’s assessment, the determination can be appealed via submission of an email request for reconsideration. Appeals will be reviewed by IU HRPP and Indiana CTSI leadership for final determination.
Trials are not considered successfully registered in the IU PRS account until the trial receives its National Clinical Trial (NCT) number and is free of errors. Errors are system validation messages in the PRS system indicating a serious issue that must be addressed.
Each time the ClinicalTrials.gov record is reviewed for accuracy, the record verification date should be updated.
Records with errors in data entry, records with modifications that have not been completed or released, and records requiring annual review that exceed 12 months without a verification action, or whose anticipated dates pass prior to being updated, will be flagged in the IU PRS portal as having Problems which must be addressed.
QIO staff will follow up regarding such records to request resolution of the error, problem, or issue. PIs should resolve such problems within 30 days.
The regulations do not permit extensions for results posting due to the need to complete routine data analysis. However, in special circumstances, the Responsible Party may request an extension to the results reporting deadline for good cause. Such extension requests must be submitted prior to the date on which results information would otherwise be due.
Research personnel must immediately notify QIO upon receipt of any correspondence from the FDA or NIH regarding potential issues of ClinicalTrials.gov noncompliance. QIO will assist the PI with any necessary actions to achieve compliance.
4.0 - Sanctions
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- 21 CFR 50.3 – FDA Regulations regarding Protection of Human Subjects, Definitions section
- 42 CFR Part 11 – Clinical Trials Registration and Results Information Submission
7.0 - Definitions related to this policy
applicable clinical trial (ACT), clinical trial, principal investigator
View All Abbreviations and DefinitionsBack to top