Clinical Trials Committee – Review Types
Any studies that require medical intervention fall into this category. This process involves two committee members conducting an initial review of the study followed by a full committee review at the next scheduled meeting. Following the meeting, the CTC advises the Investigator of any issues that require resolution prior to approval being granted.
The CTC Chair may review research activities involving no more than minimal risk through the Expedited Review procedure. Investigators may request that their study receive an Expedited Review. The CTC, however, will make the final determination. If, upon review by the Chair, the study does not meet the criteria for Expedited Review, the CTC will notify the investigator by fax and mail that a full review is required.
The following are examples of research studies that may be eligible for Expedited Review:
- Collection of excreta and external secretions including sweat, urine, uncannulated saliva, placenta removed at delivery and amniotic fluid at time of rupture of the membrane prior to or during labour.
- Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes using physical sensors applied either to the surface of the body or at a distance, but does not involve the input of matter or significant amounts of energy into the subject, or invasion of the subject’s privacy. Procedures such as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography are examples of these. However, it does not include exposure to electromagnetic radiation outside the visible range (for example: x-rays, microwaves).
- Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight-week period and no more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
- Moderate exercise by healthy volunteers.
- The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
Following review, the Investigator is advised of any issues that require resolution prior to approval being granted.
The Health Research Ethics Board of Alberta, which CTC falls under, is moving toward a reciprocity agreement with the other government designated research ethics boards in Alberta to share information relating to each of their respective Research Ethics Boards’ review of research studies. This will help avoid duplication of the review of the same research study by another party.
It is the investigator’s responsibility to determine whether another investigator has already submitted the study to one of these Research Ethics Boards in Alberta. The Chair of the CTC reserves the right to subject the proposed submission to a full Committee review.
Whether for Full, Expedited or Reciprocal review, the CTC administration staff designates the first investigator to submit application protocol for review the “Lead Investigator.” If/when the CTC receives subsequent applications from investigators at other sites in Alberta for the same research study, these investigators are designated “Additional Investigators.” These are the CTC’s terms and it is understood that there is a Qualified Investigator for each site.
Once the CTC approves the Lead Investigator’s submission, Additional Investigators can then submit their protocols with the applicable approved document versions. It is each Additional Investigator’s responsibility to obtain a copy of the approved version of the informed consent from the Sponsor. Each investigator must then place it their letterhead with their name and contact information inserted in the appropriate places. The approved version date must be in the footer of the document. The Investigator may choose to have an additional date (called a “site version date”) to reflect the date the consent was submitted from their site.
The CTC will review the application, and will notify the investigator of the review’s outcome. Please note that an investigator may also submit an application prior to the study being approved for the “Lead Investigator.”
The CTC has adapted the following guidelines from former Research Ethics Review Committee practices to assist in the submission of an Extension study. No two Extension studies are alike; therefore, the CTC considers each submission individually. The CTC intends for the following information to serve as a guide to assist you in meeting CTC requirements for Extension studies. We will update the information below as new scenarios/suggestions come forward. Please refer to this information prior to each Extension study submission.
Definition: An Extension study is one that requests:
- an extension of time to recruit additional subjects.
- an extension of time to collect more research data using the approved original study protocol.
- an extension of time that also incorporates a change in procedures, dosages or testing for the subjects.
- a “continuation phase” that was outlined in the submission of the original protocol but not completely documented.
- If you submit an extension study with the original study submission, the CTC will review the information in the course of the original review and, if appropriate, will approve it with the original protocol submission.
- The Chair of the CTC will review an extension study requesting more time to allow for recruitment of additional subjects or to collect more data separately if the Extension Study was submitted after CTC approval of the original protocol.
- If you submit an Extension study separately after CTC approval of the original study protocol and incorporates changes or additions to the procedures, dosages and/or investigations, it will require separate review by the full committee.
While in most cases it is clear whether a study protocol requires CTC review, there are situations where this determination is not so obvious.
Wherever possible, the CTC coordinator will ask questions to help the investigator determine whether you should submit the proposal to the CTC for review. Occasionally, however, the coordinator and/or the CTC Chair is required to make a preliminary assessment of the proposal in order to make a definitive determination whether or not it should be submitted for CTC review.
The Assessment fee covers the cost of assessing a proposal, and, if appropriate, providing a letter that confirms research ethics approval is not required. If the assessment determines that the proposal requires review and that you must submit the study to the CTC for review, we will deduct the fee from the normal cost of the service provided (e.g. Full Review or Expedited Review).
Contact the CTC Coordinator by writing to clinicaltrials@HREBA.ca