FAQ: Clinical Trials

Answer

Fraser Health has an organizational account with ClinicalTrials.gov. To obtain a user account for registering your clinical study with ClinicalTrials.gov, contact Susan Chunick, Director, Department of Evaluation and Research Services, who is the protocol registration system (PRS) administrator for Fraser Health. You will receive a message generated by ClinicalTrials.gov's protocol registration system that will include your username and password. Then, follow these steps:

1. Go to register.clinicaltrials.gov
2. Enter your organization, username and password. NOTE: The organization must be entered as Fraserh
3. You will then land on the main menu.
4. Scroll down to "User Account" and select "Change Password".
5. Change your password.
6. You will land on the main menu again.
7. If this is your first time registering a clinical study with ClinicalTrials.gov, scroll down to "Help" and print a copy of the "Data Element Definitions" to assist you in registering your study.
8. Scroll to "Protocol Records" and select "Create".
9. Follow the instructions provided to complete the registration of your study.

NOTE: Once a study is registered, you are responsible to ensure that the information entered is accurate and up to date (i.e. overall recruitment status, study completion date, enrollment). If during the course of the study there is a protocol amendment, the affected data elements (i.e., eligibility criteria) must be updated. This is done by selecting "Modify" under "Protocol Records".

Answer

The International Committee of Medical Journal Editors (ICMJE) has indicated that clinical trials will not be published without the registration of that trial prior to participant enrolment. In June 2007, the ICMJE expanded the types of trials requiring registration and adopted the World Health Organization’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 on health outcomes.” A trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.

Health related interventions include any intervention used to modify a biomedical or health-related outcome (i.e., 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. Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration.

Answer
Fees for submitting to the FHREB apply to all industry-sponsored studies only. The initial REB submission/review fee is $3,000.

Answer
Please refer to the Industry-sponsored Research page for complete details.

Answer
A DSMB is only required for phase III or phase IV, or complex phase II trials. You will not need a DSMB for a marketed product being used for the purpose and in the manner for which it is marketed. You will need a DSMB if you plan to have a control group or use randomization or any manoeuvre that could place an individual at risk of a side effect or missing out on a benefit.

Answer
Health Canada does not require a separate signed "Research Ethics Board Attestation Form" if Research Ethics Board (REB) Certificates of Approval includes the information stipulated by Health Canada for clinical trials. The FHREB certificates of approval include the required information stipulated by Health Canada. The FHREB will not sign a separate research ethics board attestation form.