/ VMIA Requirements for Drug & Device Trials Under CTN Scheme Checklist

Important Note : Failure to adhere to the following requirements of the VMIA may invalidate your policy coverage

Section 1 – General Requirements

No. / Description / Required / Completed
1.1 / Has the Therapeutic Goods Administration (TGA) been notified in accordance with all statutory and regulatory requirements? / Yes / No / NA / 
1.2 / If the trial is included in the following list, has the trial been approved by the VMIA’s assigned lawyers, DLA Phillips Fox?
Clinical drug or device trial with no commercial sponsorship
Commercially sponsored Phase I and Phase II clinical drug trial
Commercially sponsored device trial
Commercially sponsored Phase III and IV clinical drug trial not complying with the minimum requirements outlined in the VMIA CTN guidelines. / Yes / No / NA / 

Section 2 – VMIA Notification Requirements Prior to Commencing Phase I/II or Investigatior Initiated Trials

No. / Description / Required / Completed
2.1 / Has a copy of the following documents been provided to DLA Phillips Fox Lawyers: cover letter, registration pro forma, lay summary, scientific summary, patient information sheet and patient consent form? / Yes / No / NA / 
2.2 / For commercially sponsored trials, has an indemnity from the commercial sponsor and a certificate of insurance evidencing the commercial sponsor's insurance arrangements in respect of the trial been supplied to DLA Phillips Fox Lawyers? / Yes / No / NA / 
2.3 / Has the VMIA been provided with a copy of the cover letter? / Yes / No / NA / 
NOTE : A hospital/institution is not required to submit for approval any commercially sponsored Phase III and IV drug trial, provided the trial complies with the requirements for Phase III and IV drug trials guidelines set out in VMIA CTN guidelines. If it complies, the trial will be automatically covered by the Public Liability and Medical Indemnity Policies. If not, the requirements set out in 3.1 – 3.3 apply.

Section 3 – HREC

No. / Description / Required / Completed
3.1 / If the clinical trial involves a medical procedure and the recruitment of participants aged 18 years or over who are incapable of giving consent, has the responsible HREC ensured that the requirements of the Guardianship and Administration Act 1986 (Vic) (GAA) are met? / Yes / No / NA / 
3.2 / Where a trial is being conducted outside the HRECs institution, has the HREC determined that supervision and reporting arrangements are satisfactory? / Yes / No / NA / 

VMIA Requirements for Drug & Device Trials Under CTN Scheme Checklist continued

Section 4 –Indemnity and Insurance Requirements (Commercially sponsored Trials)

No. / Description / Required / Completed
4.1 / Is the indemnity provided by the Commercial Sponsor in a form no less favourable than the current version Medicines Australia Form of Indemnity for Clinical Trials? / Yes / No / NA / 
4.2 / Is the Commercial Sponsorship and the indemnity provided by an Australian corporate entity? / Yes / No / NA / 
4.3 / Where the trial is being conducted by private hospitals or practitioners in private practice, and the trial is reviewed by a public Hospital's HREC, has the commercial sponsor's indemnity named and fully indemnified the public hospital and its agents and servants for their participation? / Yes / No / NA / 
4.4 / Where a third party such as a researcher or other body or organisation involved in a clinical trial wishes to be indemnified by the commercial sponsor, has a separate Form of Indemnity been arranged? / Yes / No / NA / 
4.5 / Has a Certificate of Insurance been received from the commercial sponsor that satisfies the following conditions:
  • names the Australian corporate entity acting as commercial sponsor as a named insured under the relevant insurance policy;
  • evidences the existence of an insurance policy which covers the conduct of the relevant clinical trial in Australia;
  • is through an insurer either approved by the Australian Prudential Regulation Authority or an overseas insurer with a minimum;
  • evidences that the policy will be current throughout the entire period in which the clinical trial is conducted;
  • does not contain an excess/deductible or self insured retention amount greater than AUD$25,000 for each and every claim or series of claims arising out of one originating cause.
/ Yes / No / NA / 

Comments

Name of Manager:______

Signature of Manager:______Date: _____/______/_____

Melbourne Health

VMIA Requirements for Drug & Device Trials Under CTN Scheme Checklist

Version 1 dated 1 May 2011page 1 of 2