Requested Submission Date: Month and year when results are expected to be submitted.

Explanation: A written explanation that demonstrates good cause for the extension. Provide sufficient information to allow for evaluation of the request. Note that "pending publication" is not considered "good cause" for an extension. (Limit: 600 characters)

Applicable studies can request a second extension for good cause. Please note that the Database lock justification is not sufficient to be determined by Clinical Trials PRS (Protocol Registration System) Review team as "Good Cause."

Four months before the results submission deadline, SIO requests a redacted protocol document and a statistical analysis plan (SAP) document from the Clinical Project Manager (CPM). To comply with Final Rule 42 CFR (Code of Federal Regulations) Part 11 and US Public Law 110-85, a redacted protocol document and Statistical Analysis Plan (SAP) are required for NLM Results Reporting. If the SAP is not included in the finalized protocol document, this document will need to be provided to the NLM separately.

Redacted protocol documents are finalized version of a protocol. As these documents will be posted publicly on ClinicalTrials.gov, the regulations allow for the redaction of the protocol and SAP prior to submission to remove any proprietary or personally identifiable information.

Requests for redaction services can be submitted to the DMID-CROMS Medical Writing Team. If the documents do not need to be redacted, please provide confirmation that they may be posted publicly without redaction.

Sub-studies can either be integrated within the same record as the parent study or be created as a separate protocol with its own protocol number and have different Primary Completion Dates (PCDs). Please note that for all parent studies that have a sub-study within the same record, information regarding the sub-study is displayed in the protocol description field Section 1 of RSPA.

The NLM results for the delayed sub-study results data would still be required to be submitted by the Study Completion Date (SCD) + 1 year.

"Note that even though a responsible party for a trial may need to submit partial results information several times in order to meet different deadlines (i.e., because of different dates for final data collection for primary and/or secondary outcome measures or for the pre-specified time frame for collecting adverse events), that responsible party's obligation under subpart C continues until all required results information is submitted not later than 1 year following the Study Completion Date." ​(Federal Register, 2016)

Studies with separate NCT numbers are treated as separate studies. The standard submission deadline for results information is no later than 1 year after the study's Primary Completion Date (PCD).

​
Results are posted publicly by the National Library of Medicine (NLM), and can be accessed on ​clinicaltrials.gov

Results information for an ACT (Applicable Clinical Trial) must be submitted by the responsible party no later than 1 year after the primary completion date. Please refer to the following links for more information.

1. ​https://clinicaltrials.gov/ct2/manage-recs/fdaaa#WhenDoINeedToSubmitResults
2. ​https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission#sectno-reference-%E2%80%8911.40

There are potential civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements.​

In relation to federally funded studies, remaining or future grant funds from a grantee may be withheld for failure to submit clinical trial registration and results information on time. Please refer to the following links for more information.​​​​​​​​​​​​​

1. ​ https://clinicaltrials.gov/ct2/manage-recs/fdaaa#AreTherePenalties
2. ​https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission#sectno-reference-%E2%80%8911.66​
   

Refer to "Legal Consequences of Non-Compliance"​​​​​​​​​​​​

NIH and DMID definition of Applicable Clinical Trial (ACT): A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Please refer to the following link for more information.​

A protocol is eligible to have its results data posted if the following are true:​

1. DMID registered the protocol with the NLM.​​​​​​​

2. Its primary completion date is after 26-Sept-2007.​

3. The study is an applicable clinical trial.​

Exceptions to the rule:​

1. For phase I Clinical Trials, if the Grant/Proposal receipt date occurred before 18-Jan-2017 it does not meet the requirement for NLM Results Data eligibility.​

   1. This rule does not apply for Infectious Diseases Clinical Research Consortium (IDCRC) studies because the grant proposal date for all IDCRC studies is February 15, 2019.