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Presentation Guidelines

Request for Expedited Review:

Sponsors must request Expedited Review of their clinical trial or projects through CALS Headquarters. In return, CALS will:

  • Issue a letter to formally engage the Sponsor in the review process inclusive of details and financial terms. Please note that the full cost of the Expedited Review will be borne by the Sponsor requesting the review as per the letter of engagement.
  • Make all necessary arrangements to organize the review
  • Issue a call for CALS Reviewers
  • Sign a blanket confidentiality agreement on behalf of the Network
  • Provide the names and addresses of Reviewers to the Sponsor so that Sponsor can send all relevant materials (i.e. protocol, investigational brochure, related publications) directly to Reviewers, prior to the date of the review.

Review Team:

Through a centralized Call for Reviewers, CALS will bring together a cross section of available members, consultants and experts to form a Reviewer team lead by the Head Reviewer. Depending on the scope and scale of the project the Reviewer Team usually consists from 4-7 persons as follows:
Head Reviewer (usually a senior Clinician and a senior member of the Network), Chair and/or 1 other member of the Board of Directors, 1-3 additional clinician members of the Network (Active or Associate Members) possessing expertise in a given area i.e. pre-clinical, epidemiology, statistician, and an External Consultant as required.

Expedited Review Charges:

The Sponsor requesting a CALS Expedited Review will bear all expenses relating to the Expedited Review at cost. Charges incurred may involve some of the following: transportation, parking, accommodation, reviewer honoraria, room rental, food and beverage, teleconferencing, audio-visual, administrative on-site fee, and 20% corporate surcharge. CALS makes every effort to keep these costs to a minimum.

Call for Sites:

A Call for Sites is initiated indicating to CALS investigators that the clinical trial or project has been satisfactorily reviewed, all negotiations have been completed, and sites can apply to participate. Investigators intending to participate in the study are required to communicate their interest to CALS headquarters within 10 business days. CALS then forwards a "Short-List" of interested investigators directly to the Sponsor. The final selection of sites is made entirely at the Sponsor's discretion.

General Information:

  1. On - Site and Teleconference reviews generally last approximately 2-3 hours and cover experimental and clinical data.
  2. It is the responsibility of the Sponsor to send the protocol and all presentation materials directly to reviewers well before the date of review.
  3. After reviewing the protocol and prior to the meeting, the review team will create a FIRST draft of the Reviewer Assessment Report (RAP). A copy of this first draft review will be sent to all reviewers and the sponsor just before the actual review occurs. It is desirable for the SECOND draft of RAP to be completed before the review meeting ends, since the Sponsor will anticipate a finalized report within 15 business days.
  4. All Reviewers will receive Evaluation Forms to record their comments. At the end of the meeting, completed Evaluation Forms must be sent directly to the head reviewer with a copy to CALS Headquarters. Following the review, if evaluation forms are not fully completed, then they must be faxed or emailed to the both the Head Reviewer with a copy to Consortium Headquarters ASAP.
  5. Review Meeting Agenda: In brief the Sponsor will meet CALS Reviewers for approximately 1 hour. The Reviewers will then confer privately for approximately 30 minutes and then invite the Sponsor back for a further 30 minute question period and wrap up. A FINAL AGENDA WILL BE SENT OUT PRIOR TO THE REVIEW.
  6. Following the review meeting, all Reviewer Evaluation Forms must be sent to the Head Reviewer immediately so the final assessment report can be prepared. The Head Reviewer will send a composite (DRAFT) report to all reviewers following the review meeting via fax or email. The Head Reviewer is responsible for producing a finalized assessment report including the Reviewer comments. All Reviewers will be expected to comment on all drafts of the report in a timely manner. The Head Reviewer will seek final consensus from the review team to accept or reject the project, rank the project priority (low, medium, high) and determine whether the study should proceed through CALS.
  7. Scale of Remuneration and Charges: The Head Reviewer will receive a $1000 honorarium. All additional Reviewers will each receive a $500 honorarium. The honoraria will be paid to Reviewers from the Network upon completion of the Reviewer Assessment Report (RAP). The full and final cost of the review will borne by the sponsor.
  8. Reviewers who have been confirmed, but who feel that they cannot accommodate these guidelines must inform CALS Headquarters immediately, so that a replacement reviewer can be found.

 


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