POLICY AND PROCEDURE MANUAL

Transcription

1 POLICY AND PROCEDURE MANUAL PBRC: POLICY NO ORIGIN DATE: 5/25/2016 IMPACTS: CLINICAL RESEARCH LAST REVISED: 1/1/2017 SUBJECT: SOURCE: PURPOSE PENNINGTON BIOMEDICAL CLINICALTRIALS.GOV POLICY INSTITUTIONAL PRS ACCOUNT ADMINISTRATOR EFFECTIVE : 1/18/2017 VERSION NO. 2 Establish a policy that will promote consistency within PBRC to meet the requirements for registering of and reporting results of applicable Pennington Biomedical clinical trials in the U.S. National Institutes of Health (NIH) ClinicalTrials.gov database. POLICY All applicable Pennington Biomedical clinical trials must be registered in ClinicalTrials.gov according to federal and other guidelines by the designated Responsible Party. U.S. Food and Drug Administration (FDA) AA 801 and NIH Policy allow registration no later than 21 days after enrollment of the first participant. The International Committee of Medical Journal Editors (ICMJE) clinical trial registration policy requires prospective registration (i.e., registration prior to first person enrolled) of all interventional clinical studies at least 30 days prior to enrollment of the first participant. Once a trial is registered, the FDA, NIH and ICMJE require that registrations be updated regularly by the Responsible Party. ClinicalTrials.gov notifies the Principal Investigator (PI) or designee account of which trials are due for updates. Per FDA and NIH updating requirements, information must be updated at least every 12 months and the registry must be updated within 30 days of any changes in recruitment status or completion of study. ICMJE requires updating study information every 6 months. Results information submission is also required for Applicable Clinical Trials that were required to be registered under FDAAA 801 and that study drugs, biologics, or devices that are approved, licensed, or cleared by FDA. In general, results of an applicable clinical trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Responsible Party no later than 12 months after the Primary Completion Date. Results submission is also now required for all applicable NIH funded studies no later than 12 months after the Primary Completion Date. For each applicable clinical trial, Pennington Biomedical Investigators are ultimately responsible for: ensuring that said clinical trials are registered in Clinical Trials.gov in a timely manner by the Responsible Party (Sponsor or Principal Investigator(PI)); reviewing the content of the Clinical Trial information posted on Clinical Trials.gov; 1 P a g e

2 notifying the Responsible Party (Sponsor or PI) and the Pennington Biomedical Institutional Protocol Registration and Results System (PRS) Administrator of any inconsistencies and/or errors in the Clinical Trial record; reviewing the Clinical Trial Record as required to verity that updating is taking place as required; and assisting the Responsible Party (Sponsor or PI) in reporting Clinical Trial results as appropriate. OVERSIGHT / ENFORCEMENT To serve in the oversight capacity, Pennington Biomedical will appoint an Institutional PRS Administrator. The PRS Administrator can assist with: establishing user accounts and temporary passwords; resetting a password when the original is lost or forgotten; changing ownership of a study; or transferring a study to another institution. The Pennington Biomedical PRS Administrator will also monitor the system and notify Responsible Parties when updating and/or addressing problems is not completed in a timely manner. The Administrator will offer basic training in the use of the PRS interface and will assist with basic tasks of Clinical Trial registration but is not responsible for reviewing/editing the content of the information posted on ClinicalTrials.gov. This falls solely under the purview of the PENNINGTON BIOMEDICAL PRINCIPAL INVESTIGATOR and the Responsible Party identified for each applicable Pennington Biomedical clinical trial registered. According to the FDA/NIH (FDA Amendments Act of 2007/NIH Policy on Dissemination of NIH Funded Clinical Trial Information effective January 18, 2017): Penalties may include civil monetary penalties up to $10,000 fine for failing to submit or for submitting fraudulent information to ClinicalTrials.gov. After notification of noncompliance, the fine may go up to $10,000 per day until resolved. For all NIH federally funded grants, penalties may include the suspension/termination of grant/contract funding. In addition, failure to register applicable trials by an investigator can be considered in future funding decisions. Failure to register applicable clinical trials could also delay Institutional Review Board (IRB) continuing review approvals for protocols and may also result in the inability to publish the results of the trial in an ICMJE-associated journal. SCOPE / AUTHORITY The FDA is the government agency that requires registration of clinical trials. The FDA Amendments Act of 2007 (FDAAA or U.S. Public Law ) passed on September 27, 2007 requires mandatory registration and results reporting for certain clinical trials of drugs, biologics, and devices. The NIH is the government agency that has issued a complementary policy to the FDA Amendments Act of 2007 entitled NIH Policy on Dissemination of NIH-Funded Clinical Trial Information ( effective date January 18, 2017). This policy applies to clinical trials funded in whole or in part through the NIH 2 P a g e

3 extramural and intramural programs. For the NIH extramural program, the policy applies to applications for funding including for grants, other transactions, and contracts submitted on or after the policy s effect date that request support for the conduct of a clinical trial that is initiated on or after the policy s effect date. For the NIH intramural program, the policy applies to clinical trials initiated on or after the policy s effective date. The policy does not apply to a clinical trial that uses NIH-supported infrastructure but does not receive NIH funds to support its conduct. The ICMJE member journals require, as a condition of consideration for publication in their journals, registration in a public trials registry. The ICMJE does not advocate one particular registry, but its member journals require authors to register their trial in a registry that meets several criteria. ClinicalTrials.gov meets these requirements. DEFINITIONS ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world; service provided and maintained by the NIH. The PRS is a web-based data entry system used to register the clinical studies and submit results information for registered studies. Researchers must have a PRS account to register study information on ClinicalTrials.gov. Applicable Clinical Trial is a clinical trial that generally includes interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions: The trial has one or more sites in the United States; The trial is conducted under an FDA investigational new drug application or investigational device exemption; The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research. Applicable Clinical Trials include the following: Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a product subject to FDA regulation; Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation (other than small feasibility studies) and pediatric postmarket surveillance studies. Clinical trials funded in whole or in part through the NIH extramural and intramural progams. Studies that will be reported for publication in an ICMJE member journal. Responsible Party refers to the entity or individual who is responsible for registering a clinical investigation and submitting clinical trial information to the Clinical Trial Registry Data Bank, according to FDAAA The Responsible Party can be either: The sponsor of the clinical trial or The PI of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA's requirements for the submission of clinical trial information. 3 P a g e

4 Registration information consists of descriptive information, recruitment information, location and contact information, and administrative data. Primary Completion Date is the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated. Results Information includes participant flow, demographic and baseline characteristics, outcomes and statistical analyses, adverse events, the protocol and statistical analysis plan, and administrative information. REFERENCES A Pennington Biomedical ClinicalTrials.gov Standard Operating Procedures (SOP) document is available on the Clinical Research section of the PINE system at The regular updating and maintenance of this document will be the sole responsibility of Pennington Biomedical PRS Administrator. NIH Guidance on Clinical Trials Registration in ClinicalTrials.gov (includes new NIH Policy and new HHS rule effective January 18, 2017) Federal Register 81FR64981 Clinical Trials Registration and Results Information Submission ICMJE Obligation to Register Clinical Trials 4 P a g e

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