Office of Research Integrity
HRPP 4.12 Clinical Trials Registration Policy and Procedures
Policy Name:Clinical Trials Registration Policy and Procedures
Section : HRPP 4.12
Effective Date: 01/27/2012
Replaces Policy: 02/20/2009
The FDA and the International Committee of Medical Journal Editors (ICMJE) each have their own registration requirements. While some of the requirements overlap, there are also significant differences. In order to comply with new laws and preserve the ability to publish in ICMJE journals both sets of requirements must be met.
B. FDA Clinical Trials Registration
In September 2007, the FDA Amendment Act expanded the ClinicalTrials.gov requirements previously established in the 1997 FDA Modernization Act (FDAMA) requiring registration of trials testing drugs for life threatening diseases and conditions. This new FDA policy:
1. Expands the types of trials that must be registered to all clinical trials for drugs, devices, and biologics with the exception of Phase I drug trials and small device feasibility studies.
2. Increases the data elements that must be included in the registration.
3. Results of trials must be registered within 3 years of the completion of the primary aim of the study. The process for registration of results is in development
C. ICMJE Clinical Trials Registration
Effective July 1, 2008, the ICMJE revised its policy of June, 2005.The new policy requires the registration of all clinical trials including Phase I and pharmaco-kinetic trials. ICMJE defines clinical trials as:
1. Any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome.
2. ICMJE Signatories: New England Journal of Medicine, Journal of the American Medical Association, Annals of Internal Medicine, The Lancet, The Medical Journal of Australia, The New Zealand Medical Journal, Norwegian Medical Journal, Canadian Medical Association Journal, Croation Medical Journal, Dutch Journal of Medicine, Journal of the Danish Medical Association
A. Updating Registrations:
Once a trial is registered, both the FDA and the ICMJE require that registrations be updated as follows:
1. FDA updating requirements:
a) Information must be updated at least every 12 months
b) Additionally, the registry must be updated within 30 days of any changes in recruitment status or completion of study.
2. ICMJE requires updating study information every six months.
B. Who is responsible for registration?
1. For FDA Registration
The sponsor of the drug or device clinical trial, as defined/identified under the FDA regulations, is responsible for registering the trial. This could be either the company or the investigator.
If the sponsor is the company, the company at its discretion, can delegate the principal investigator as the "responsible party." This may only be done when "the principal investigator 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 the requirements" for submitting information under the law
2. For ICMJE Registration
While anyone involved in the clinical trial could register the trial, in practice this responsibility usually falls with the individual submitting the publication to the ICMJE journal, which is usually the Principal Investigator.
C. Deadline for Registration
Compliance with the ICMJE is only required if publication in one of the relevant journals is planned. In contrast, compliance with the FDA regulations is required for relevant trials. If there is any possibility of submission to an ICMJE journal for publication, ensure compliance with both registration requirements.
D. Registering a Study
The Medical University of South Carolina has established an online Information Sheet detailing the instructions for clinical trials registration. The following Account Application Process must be used for registration. The University has an organizational account with the ClinicalTrials.gov Protocol Registration System (PRS). To request an individual account to enter protocol information, use the following steps:
1. Send an email to ORSP@musc.edu and type "Request ClinicalTrials.gov account" in the subject line.
2. Enter your name and NetID (This will be your user name for the system.) in the subject of the email. You will be contacted when you account is activated.
3. You may request accounts for investigators and assistants. Keep in mind that only the individual who created the record (the owner) has access to it. You may preview and print it for checking and distribution. System administrators may also change ownership of the protocol but only the owner has access.
4. Once the account is established you may login in to the registration system using this URL for the PRS login https://register.clinicaltrials.gov/. Our Organization name for the login is: MUSouthCarolina
5. Once you are in the system, follow the directions to complete the protocol information.
III. Informed Consent Requirement
The Food and Drug Administration (FDA) is amending the current informed consent regulations (21 CFR Part 50) to require that informed consent documents and processes for applicable drug (including biological products) and device clinical trials include a specific statement that clinical trial information will be entered into a databank.
The compliance date of this final rule is March 7, 2012, for clinical trials that are initiated on or after the compliance date.
When seeking informed consent for applicable clinical trials, the following statement shall be provided to each clinical trial subject in informed consent documents and processes. This will notify the clinical trial subject that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank under paragraph (j) of section 402 of the Public Health Service Act.
The statement is: ``A description of this clinical trial will be available on 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.'''