FAQ: Clinical Trials Insurance and Indemnity
As a result of the new policy directive, will I have to update all the certificates of currency that apply to clinical trials that are in progress? | Does the policy apply to annual renewal certificates for previously authorised clinical trials (i.e. those submitted prior to the policy publication date)? | I have SSAs for clinical trials that were submitted prior to the policy publication date that have not been authorised yet. Am I required to request an updated certificate? | Section 2.2.2 16(c) of PD2011_006 requires that the insurer issuing the insurance policy is either APRA-approved or (if an overseas insurer) has a minimum S&P credit rating of A- or better. How do I find this out? | Is there any leeway period for sponsors who do not meet the $20M coverage limit? | Many of our sponsors submit annual renewable certificates of currency, detailing coverage for their trials that apply from year to year. Is it still acceptable to accept yearly certificates as evidence of coverage, or do we need to insist on full coverage up front covering the whole clinical trial, which could go for a number of years?As a result of the new policy directive, will I have to update all the certificates of currency that apply to clinical trials that are in progress?
No. The publication date on Policy Directive (PD2011_006) is 25 January 2011 and the policy is prospective. It does not apply to clinical trials that were submitted for HREC review prior to the publication date. Even if final ethics approval or site authorisation for these clinical trials is granted after this date, the policy will not apply to those trials (so long as they were submitted prior to 25 January 2011).
Does the policy apply to annual renewal certificates for previously authorised clinical trials (i.e. those submitted prior to the policy publication date)?
No. Policy Directive (PD2011_006) only applies to clinical trials submitted for HREC review on or after 25 January 2011. Annual certificates of currency advising of renewed coverage for trials that were submitted prior to 25 January 2011 will not be required to comply with the policy. That is, studies approved in previous years will continue to operate under the original conditions of approval for the life of the trial.
I have SSAs for clinical trials that were submitted prior to the policy publication date that have not been authorised yet. Am I required to request an updated certificate?
No. If the study documentation was submitted prior to 25 January 2011, then Policy Directive (PD2011_006) does not apply, even if site authorisation has not yet occurred.
Section 2.2.2 16(c) of PD2011_006 requires that the insurer issuing the insurance policy is either APRA-approved or (if an overseas insurer) has a minimum S&P credit rating of A- or better. How do I find this out?
Standard and Poor's website contains this information:
You will need to register as a user, and then you can search using the ratings tab. Alternatively, you can request the insurer to confirm their rating.
Insurers who are listed on the Register of Authorised Insurers approved by the Australian Prudential Regulation Authority (APRA) are listed on the APRA website:
Is there any leeway period for sponsors who do not meet the $20M coverage limit?
No. All clinical trials submitted for HREC review on or after 25 January 2011 are required to comply with Policy Directive (PD2011_006).
Many of our sponsors submit annual renewable certificates of currency, detailing coverage for their trials that apply from year to year. Is it still acceptable to accept yearly certificates as evidence of coverage, or do we need to insist on full coverage up front covering the whole clinical trial, which could go for a number of years?
Sponsors can choose either (i) to insure for total length the clinical trial up front, or (ii) take out annual insurance. If they choose to take out annual insurance, each year they will need to present an annual certificate of currency demonstrating their compliance with the insurance requirements set out in Policy Directive (PD2011_006).