Last updated April 2011
For investigator-initiated studies, where registration is the responsibility of a McMaster-affiliated PI and funds are held in a McMaster research account, then McMaster University should be identified by the PI as the “Sponsor” (or Hamilton Health Sciences or St. Joseph’s Healthcare Hamilton if the funding is administered through a research account at either of those institutions instead of McMaster) and the funding source (e.g. CIHR, Heart & Stroke, etc.) should be noted as the “Collaborator”.
If you determine that you need to register your clinical trial and wish to do so through ClinicalTrials.gov (http://prsinfo.clinicaltrials.gov/) you will require a user account:
Is your organization already registered with the PRS? Please note that YES, each of McMaster University, Hamilton Health Sciences and St. Joseph’s Healthcare Hamilton have PRS Organizational Accounts. The PRS Administrators are indicated below:
The International Committee of Medical Journal Editors (ICMJE) announced that in order for clinical trial results to be considered for publication in journals that adhere to ICMJE standards, all clinical trials that start recruiting patients or volunteers on or after July 1, 2005 must be registered with a public registry before the enrolment of the first subject. Ongoing trials not registered at inception will be considered by the ICMJE for publication if they are registered before September 13, 2005. All trials with recruitment completed before July 1, 2005 need not register.
Details of the ICMJE requirement are described at the ICMJE website at http://www.icmje.org/
Initially, the ICMJE http://www.icmje.org/ required registration of all clinically directive trials, which it defined as “any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.” In May 2005, the ICMJE clarified this definition to exclude preliminary trials designed to study pharmacokinetics or major unknown toxicity (phase 1 trials). However, the ICMJE recognizes the potential benefit of having information about preliminary trials in the public domain, because these studies can guide future research or signal safety concerns.
Consequently, the ICMJE is expanding the definition of the types of trials that must be registered to include these preliminary trials and adopts the WHO’s definition of clinical trial: “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes.” Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrollment on or after July 1, 2008.
Note this important advice from the ICMJE: “Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal”.
Over the time during which registration of trial methods has become common practice, several forces have begun advocating for registration of trial results. The ICMJE recognizes that the climate for results registration will probably change dramatically and unpredictably over coming years.
For the present, the ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (
No. It makes no difference who the sponsor is or whether there is an external sponsor.
Acceptable registries must:
The ICMJE (http://www.icmje.org/faq_clinical.html) has reviewed the following registries and are certain that they meet the above criteria as of January 2006.
In addition to the above registries, starting in June 2007 the ICMJE will also accept registration in any of the primary registries that participate in the WHO International Clinical Trials Portal (see http://www.who.int/topics/clinical_trials/en/).
If you wish to register through ISRCTN, access the on-line application at http://www.controlled-trials.com/isrctn/submission/ . You can log-in immediately and register your trials. Once the form has been submitted, you will get an email confirming receipt of your application, which you may print out for your records if you wish. The ISRCTN editorial office will then check whether the application is eligible. An administrative charge will then be requested – the 2011 rate is £167 per trial. All users will have permanent free access to the information in the ISRCTN Register. If you have any questions about the registration process, please feel free to email firstname.lastname@example.org
No. The ClinicalTrials.gov registry allows for trials to be registered ‘pending’ ethics approval. However, once a trial has been approved by the REB, the registry must be updated with the REB approval number.
The McMaster-affiliated REBs expect that PIs will register and will continue to update the registration information (e.g when the trial is complete or results are published).
The Application for REB Review now includes a section asking whether a clinical trial has been or will be registered. If there are no plans to register the trial, the PI is asked to justify why registration is not planned.
PIs of CIHR-funded randomized controlled trials, please note that with the publication of the December 2010 version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) http://www.cihr-irsc.gc.ca/e/43756.html previous CIHR policy re trial registration has been superseded. The TCPS-2 addresses registration in Chapter 11 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter11-chapitre11/#toc11-1b, and calls for registration in any WHO/ICMJE approved registry. The premise of the WHO ICTRP Platform is that unless government (or other) requirements mandate it, a clinical trial should only be registered once in a WHO/ICMJE registry http://www.who.int/ictrp/trial_reg/en/index1.html.
TCPS-2 Article 11.3 states: Clinical trials shall be registered in a registry that is compliant with the criteria set by the World Health Organization (WHO) http://www.who.int/ictrp/en/ or International Committee of Medical Journal Editors (ICMJE) http://www.icmje.org/update_sponsor.html as of November 2010. Researchers shall provide the REB with the number assigned to the trial upon registration.
Industry-sponsored trials – Where there is a contract between the industry sponsor, the host institution, and the PI, then the industry sponsor should register the trial. Before enrolling study subjects, every PI should ensure the industry sponsor has registered the trial. The PI should also check the registry to ensure that all ICMJE minimal data set elements are included in the registration.
Investigator-initiated trials –
(a) Where industry has supplied the study drug or grant funds, the trial should be registered by the lead PI, through the sponsoring institution (e.g. McMaster, Hamilton Health Sciences, or St. Joseph’s Healthcare, as the case may be).
(b) Where the trial is either unfunded or funded through a grant from CIHR, non-profit sources, or internal sources, the trial should be registered by the lead PI, through the sponsoring institution (e.g. McMaster, Hamilton Health Sciences, or St. Joseph’s Healthcare, as the case may be).
NIH-sponsored trials – Where the trial is funded through an Institute under the National Institutes of Health (NIH) umbrella, then the Institute will register the trial.
Multi-site trials – Registration should be coordinated among the study sites and registered by the “lead sponsor” to avoid multiple registrations.