TPD/BGTD Frequently Asked Questions

Date 2005-12-01

Contact: erci-iace

Enhanced Review Capacity Initiative - Scientific Expert Database

A) Enhanced Review Capacity Initiative (ERCI)

Q: What is the Enhanced Review Capacity Initiative?

A: ERCI is a component of Health Canada's Therapeutic Access Strategy (TAS) and the Therapeutic Product Directorate's (TPD) Business Transformation Strategy. This initiative involves building internal scientific capacity as well as the appropriate use of expert advice from external sources such as drug or disease experts, professional associations, scientific advisory panels or academic institutions.

Q: How does ERCI tie to the Expert Advisor Database?

A: As part of the business process improvement, the focus is on developing more streamlined and efficient contracting processes within a targeted client-service environment. The goal is to provide centralized contracting modalities, an expert advisory database and an outreach strategy to increase the use of scientific contracts and subsequently expedite drug and medical devices reviews.

B) Scientific Expert Database (SED)

Q: What is SED and its capabilities?

A: SED is an inventory databank that will store qualified pool of external scientific experts who will be called on an as-needed basis to assist the TPD in various activities.

SED will support a collection of expert advisors with profile information, their areas of expertise, professional qualifications/credentials and security status.

SED will support selection of expert advisors and a history set-up of expert advisor contracts. It will also support TPD processes relating to expert advisor involvement in scientific advisory, reconsideration panels and committees.

SED will support a Search for qualified expert advisors, and it will serve to satisfy statistical reporting requirements, as well as those relating to expert advisor contract volumes.

Q: Who will be using the SED?

A: Office of Business Transformation: a core group of four to five people who will generate and maintain the personal information in the SED.

TPD Review Bureau: a group of 70 to 80 TPD review bureau users who will require access to the SED to identify qualified experts or panel members for consideration for an assignment. These users will have access to the search and reporting capabilities of the SED.

Expert Advisors: a group of 500 to 1000 external scientific, researchers, academia and other resources who will have the ability to complete an on-line application to be considered for qualification under TPD's expert advisory program.

Q: Where do I register?

A: If you are interested in becoming part of the SED please click on hyperlink
www.healthcanada.gc.ca/erci and register on-line.

Q: How long will my personal information be stored on the SED?

A: Personal information in the SED will be maintained on annual basis.
Unless a consent from an applicant to withdraw is obtained, the information will be retained on the database for 3 years.
If an application in not accepted, the retention of personal information will be retained only for 1 year.

C) Conflict of Interest

Q: Why is Conflict of Interest important?

A: Due to privileged and confidential nature of information which may be provided to the external reviewer during assigned work may be perceived to have a personal interest that may affect the conduct or reporting of specific drug or medical device review.

Q: What if there is a Conflict of Interest am I automatically disqualified?

A: If any of the proposed questions provide a conflict of interest, it does not necessarily mean that a potential resource is disqualified from consideration for an assignment; however, the details surrounding the positive response will require further discussion with the Health Canada Manager.

D) Security

Q: Why do I need a Security Clearance?

A: Prior to performance of any obligation under any contract, a contractor/sub-contractor and their employees assigned to the performance of such contract need to be cleared by the federal government at the Reliability level.

Q: How long does it take to obtain security clearance?

A: Reliability Status (enhanced):
2 to 5 days to process on the condition that the forms have been completed in full and fingerprints are not required from the RCMP for positive identification. If fingerprints are required, the waiting period to obtain the results from the RCMP is approximately 8 weeks.

Secret Clearance: 2 to 4 weeks (Prior to precessing the Secret clearance a Reliability Status is complete therefore the same conditions apply).

Top Secret: 8 months to 1 year for a new request (field investigation is conducted by CSIS). Updates can be done under 2 months.

Q: How should Health Canada's documents be handled?

A: a contractors/sub-contractor is required to meet the Government of Canada's Security Policy for collecting, controlling, storing and transporting sensitive information up to the Protected "B" level on behalf of Health Canada. Before forwarding any "Protected" information, Health Canada's Project Authority shall first ensure that the contractor/sub-contractor has been security screened to the "Reliability Status" security level (formerly Enhanced Reliability).

Health Canada's Project Authority must also ensure that the appropriate physical security safeguards for Protected "B" information are met at the contractor's/sub-contractor's facilities. The minimum storage and handling requirements for Protected "B" information are as follows:

  • All information should be stored and processed in an "Operations Zone" (An Operations Zone is an area where access is limited to security screened personnel who work there (need-to-know principle) and to properly-escorted visitors.
  • All information must be locked up (all lockable commercial office furniture, commercial door locks are suitable) when not in use.
  • Periodic monitoring on a regular basis must also be conducted by the contractor/sub-contractor to ensure there has not been a breach of security.

E) Contracts

Q: Can Health Canada award two or more contracts at one time to the same expert advisor?

A: Yes, as long the contracts are not for the same project or similar work.

Q: What is a contract?

A: An agreement between a contracting authority and a person or firm to provide a good, perform a service, construct work, or to lease real property for appropriate consideration.

Q: What is a Short Form Contract?

A: A short form contract is for requirements up to $10K (including GST or HST).

Q: What is a Long Form Contract?

A: A long form contract is for requirements exceeding $10K - up to $ 25K (except Temporary Help, Standing Offers and MOUs).

Q: What is a Statement of Work?

A: A Statement of Work is a narrative description of the required work. It stipulates the deliverables or services required to fulfill the contract, and it defines the task to be accomplished or services to be delivered in clear, concise and meaningful terms.

Q: What is a proposal?

A: A tender, bid or offer, either unsolicited or submitted in response to an invitation from a contracting authority. A proposal is usually requested when a contractor is to be chosen on the basis of the performance offered rather than on price alone. Proposals may require details such as the firm's qualifications and experience and the identification of problems and proposed solutions.

Q: What is contract splitting?

A: The practice of unnecessarily dividing an aggregate requirement into a number of smaller contracts, thereby avoiding controls on the duration of assignments or contract approval authorities.

Q: What is a competitive contract?

A: A contract where the process used for the solicitation of bids enhances access, competition and fairness and assures that a reasonable and representative number of suppliers are given an opportunity to bid.

Q: What is a non-competitive contract?

A: Any contract for which bids were not solicited or, if bids were solicited, the conditions of a competitive contract were not met.

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