Legal & Regulatory Documents. Angela Henjak, Alfred Health

Transcription

1 Legal & Regulatory Documents Angela Henjak, Alfred Health

2 Documents Clinical Trial Notification (CTN) Form Insurance certificate Indemnity Research Agreement Information can be found on our Legal & Regulatory Requirements page:

3 CTN Form Notifies TGA of trials conducted at each Site Allows for access to unapproved medicines and devices Unapproved medicines or devices: Medicines or devices which do not appear in the Australian Register of Therapeutic Goods (ARTG) ARTG goods used outside of the marketing approval, eg different indication, dose, formulation, route of administration

4 CTN Form Need to nominate the Sponsor of the trial The Sponsor is the company, organisation, institution, body or individual (enterprise) that initiates, organises and supports a clinical study of an investigational product on human subjects. Commercially sponsored studies: the Local Sponsor Collaborative group studies: the Collaborative Group Investigator-initiated studies: the Institution which is the custodian of the Protocol, eg Alfred Health, Monash University, Baker Heart & Diabetes Institute, The Sponsor has to be an Australian entity

5 CTN Form The CTN submission process is now online It is the responsibility of the Sponsor of the Study to do the online submission Alfred Health will submit and send an invoice to researchers A CTN Form which captures the information will need to be completed An excerpt or draft CTN form is required for all submissions Remember to include placebo Complete Devices section Includes devices which are TGA-approved but are imported directly from overseas, eg ECG machines, point of care devices, blood collection tubes ECG machines and point of care devices require statement in the PICF

6 Insurance Certificate An insurance certificate is required from the custodian of each Protocol, eg commercial sponsor, collaborative group, research institution, hospital etc. Commercially sponsored studies: Needs to nominate the Local Sponsor (full legal name) listed on the CTN form as an Insured or an Additional Insured. Certificate Holder is not acceptable Limit of Liability: The class of insurance should be for Public and Product Liability or equivalent such as General Liability or Clinical Trial In Victoria: $10 million per occurrence and in the annual aggregate In NSW: $20 million per occurrence and in the annual aggregate

7 Insurance Certificate Deductible (excess) is not to exceed $25,000 for each and every claim or series of claims arising from a single cause. If the certificate lists the Study title and Protocol Number, these details must be correct. The certificate should be current throughout the trial period. Need to check details on renewed insurance certificates have not been altered.

8 Indemnity Required for commercially sponsored studies Some collaborative groups provide an indemnity but not required Not required for investigator initiated studies

9 Indemnity There are two kinds of indemnities: Standard indemnity: > Covers the conduct of study at the site as well as the HREC review > Always required HREC Review Only indemnity: > Necessary if HREC is reviewing for other sites > Required for streamlined applications (SERP & NMA)

10 Indemnity There are separate indemnities for drug and device trials Drugs: Medicines Australia (MA) Devices: Medical Technology Association of Australia (MTAA) The name of the Compensation Guidelines for drugs and devices differs slightly: Drugs: Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Trial Devices: Guidelines for Compensation for Injury Resulting from Participation in a Company-Sponsored Clinical Investigation Compensation wording in the PICF should reflect the correct: Peak body: MA or MTAA Compensation Guidelines Full legal name of the Local Sponsor

11 Indemnity Please use the CTRA & Indemnity Checklist to check details are correct: To clause which defines the Indemnified Party From clause which defines the Sponsor Re clause: Study title and Protocol Number Paragraph Number 1 Standard indemnity: > Correct participant group selected: patients of the Indemnified Party or non-patient volunteers > Correct name of Principal Investigator

12 Indemnity Please use the CTRA & Indemnity Checklist to check details are correct: Paragraph Number 1 HREC Review Only indemnity: > Correct participant group selected: patients of the Indemnified Party or non-patient volunteers > Correct, legal name of each Site > Correct name of each Site Principal Investigator

13 Research Agreements The Australian Code requires that an Agreement be signed for each trial, even investigator-initiated studies Agreements cover issues such as Obligations and responsibilities of each Party Indemnity and insurance requirements Payment Publication restrictions Authorship Intellectual property Contact the Ethics or Research Governance Office if unsure If there are intellectual property issues, please seek legal advice from your Institution

14 Research Agreements Commercially Sponsored and Collaborative Group Studies: Drug Trials: > Medicines Australia Standard Form > Medicines Australia Contract Research Organisations (CROs) acting as the Local Sponsor > Medicines Australia Collaborative or Co-operative Research Group (CRG) Studies > Medicines Australia Phase IV Clinical Trials

15 Clinical Trial Research Agreements Commercially Sponsored and Collaborative Group Studies: Device Trials: > Medical Technology Association of Australia Standard Clinical Investigation Research Agreement (CIRA)

16 Research Agreements Investigator-initiated, Company Supported Studies: Alfred Health template Investigator-initiated Studies: Clinical Trials: > VMIA investigator-initiated: Accepted in Victoria and some interstate sites > Medicines Australia Collaborative or Co-operative Group (CRG): Accepted by interstate sites

17 Research Agreements Investigator-initiated Studies: Non-Clinical Trials: > Alfred Health Research Collaboration Agreement Material Transfer Agreements (MTAs): Governs the exchange of materials between two organisations, usually for research purposes and should be used for the transfer of tissue and other material Two types of MTAs: incoming and outgoing

18 Research Agreements There are templates for Research Agreements and indemnities Please use the CTRA & Indemnity / Research Agreement Checklists to correctly complete and check the CTRAs. The body of the indemnity or Agreement template should not be altered For Agreements, changes should be detailed in: Schedule 7 for commercially sponsored template Schedule 4 for collaborative group and VMIA investigator-initiated template Schedule 3 for Research Collaboration Agreement and investigatorinitiated, company supported template

19 Legal Documents Please submit the signed CTRA & Indemnity / Research Agreement checklist Need to be submitted for review Should only be signed by authorised representatives Principal Investigator: Should NOT sign as a Party, eg agree to be bound by the terms Should sign as read and acknowledged the terms

20 Confidential Disclosure Agreements (CDA) Many are currently signed by the Principal Investigator Some institutional CDAs have been signed Medicines Australia is working on a CDA template

21 Changes to Legal & Regulatory Documents CTN Form: Changes which require an amended CTN form: > Drug details: dosage, route of administration, strength > Device details > Sponsor > Study Title > Principal Investigator > Addition of Sites

22 Changes to Legal & Regulatory Documents Insurance Certificate: Changes which require an amended insurance certificate: > International Sponsor > Local Sponsor > Study title and Protocol Number if listed

23 Changes to Legal & Regulatory Documents Indemnity Standard and HREC Review Only: Changes which require an amended indemnity: > Local Sponsor > Study Title > Principal Investigator(s)

24 Changes to Legal & Regulatory Documents Research Agreements: Any revisions are to submitted as an Amendment or Addendum to the Agreement rather than an entire new Agreement There are templates on our website

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