Clinical Trials Committee – Review Types

Full Review

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.
Please see the section on Full Protocol Review in Checklists for Submission of a Research Study for a list of the requirements for submission of a study for Full Review.

 

Delegated Review

The CTC Chair may review research activities involving no more than minimal risk through the Delegated Review procedure.  Investigators may request that their study receive an Delegated Review. The CTC, however, will make the final determination.  If, upon review by the Chair, the study does not meet the criteria for Delegated Review, the CTC will notify the investigator via IRISS that a full review is required.
Genetic studies and studies that involve medical intervention would not normally be eligible for Expedited Review.

 If you are unsure if a protocol can be submitted as an Delegated Review, please refer to the ARECCI Guidelines and Ethics Screening Tool to help determine the appropriate review requirements and risk level of your protocol.

The following are examples of research studies that may be eligible for Delegated Review:

Delegated Review- Minimal Risk Studies:

  • 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.
  • 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.

 

Delegated Review – Additional Investigator Studies:

  • The protocol is previously reviewed at a full board meeting and approved by the CTC. An additional, separate site can be then be approved for the same study.  Since the study documents were already approved by the CTC, the additional site would be a delegate review to check if all documents are verbatim and to check for any significant differences in application responses.
  • Whether for Full, or Delegated 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 documents. It is each Additional Investigator’s responsibility to obtain a copy of the currently 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.
  • Please see the section on Multicentre Studies in Checklists for Submission of a Research Study for a list of the requirements for these submissions.

 

Delegated Review – Reciprocal Studies

  • If the protocol is approved by the University of Alberta or University of Calgary research ethics board, you can submit your study as a Reciprocal
  • 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 duplication of the review of the same research study by another party can be avoided.
  • 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.
  • Please see the section on Reciprocal Reviews in Checklists for Submission of a Research Study for a list of the requirements for submission of a study for Reciprocal Review.

 

Extension Studies 

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.

Procedures:

  1. 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.
  2. 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.
  3. 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.

Please include a brief synopsis of the main study in the extension study IRISS application form and informed consent form.


Questions?  Contact the CTC Coordinator by writing to clinicaltrials@HREBA.ca