Clinical TRIAL Initiationchecklist

Clinical TRIAL InitiationChecklist

Principal Investigator name:
Protocol name/number: / HREC Reference number:
Only once each item is checked YES or N/A may your initiate your trial and start recruiting participants.

1. ETHICS AND GOVERNANCE APPROVAL RECEIVED

Do you have a written and dated ethics approval certificateAND authorisation to commence certificate for the trial, listing the current protocol, informed consent form and all other applicable documents? / YES☐

1. Budget and resourcing finalised

Have you finalised the trial budget and ensured that you have available adequate funds, adequate time, an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct it properly and safely? / YES ☐

1. Study Files established

Have all forms (including Case Report Forms) and all procedures necessary to ensure protocol and regulatory compliance been finalised (e.g. investigational product accountability log).
Have study-level files been established and all required documentation filed.
Have you set up participant-level files. / YES ☐

1. STUDY TEAM ROLES AND RESPONSIBILITIES FINALISED

Have you ensuredthat all staff with responsibilities in the trial are adequately trained and have an adequate understanding of the protocol, the investigational products, and their study-related duties and functions? Have you documented this (e.g. training log).
Have all research team members completed the “Delegation of Responsibilities Log”. / YES ☐
YES ☐

1. Provisions for SUPPORT and services FINALISED

If the study involves the services or support of other departments, research enablers or external service providers(e.g. clinic, Hobart pathology), have you finalised agreements and arrangements necessary for thetrial. / YES ☐
N/A ☐

1. adequate EQUIPMENT AND supplIES ARE AVAILABLE

Have you confirmed the receipt or availability of all equipment and supplies crucial to the trial including the study drug or device, lab kits etc? / YES ☐
N/A ☐

1. SPONSOR/ORGANISING GROUP APProvAL GRANTED FOR INITIATION OF study

If your study is an externally sponsored/coordinated trial, do you need a written, dated statement approving commencement of the study? Have you received this? / YES ☐
N/A ☐

1. Clinical Trial Registration

All clinical trials must be registered on a public trial register within 21 days of the first participant enrolment. / YES ☐
DRUG/DEVICE TRIALS ONLY

1. Clinical trials notification (CTN) complete

Has a CTN form been submitted to the Therapeutic Good Administration (TGA)? / YES ☐

1. Investigational drug/device supplies AVAILABLE

Have you received the study drug or device? / YES ☐

Version draft

5 Sept 2016 Page 1 of 1