1. GENERAL INFORMATION
Full Study Title and Trial Number:
PI Undertaking Study:
Intended Study Commencement Date:
HREC Submission Date:
Date of Site Selection:
Assigned Lead CTC:
Start Up Primary Contact Sponsor/CRO: Name:
Study Primary Contact Sponsor/CRO: Name: as above
Sponsors Intended Commencement Date:
HREC Approval Date:
Would any of the following factors make it difficult to identify suitable patients?
N = No Y = Yes P = Potentially NA = Not Applicable
Drug/device application/ route of administration
Lack of scientific import
Are there any current or planned competing studies?
Is there another option available for obtaining the intervention/treatment that may affect recruitment?
Is the trial open to competitive recruitment?
Projected end of recruitment?
What is the source of patients and how will they be identified?
Percentage of eligible patients that is likely to enrol in the study?
Estimated total recruitment for the study duration?
3. INVESTIGATOR TEAM RESOURCES (STAFF/EQUIPMENT/TIME)
Appropriate Investigator/s clinical trial experience:
Appropriate Coordinator/s clinical trial experience:
Appropriate time for the investigator/clinical team to undertake study visits and procedures?
Appropriate time and capacity for CRF and source document completion, query resolution, monitoring visits, and other administrative requirements?
Are there adequate staff resources including the requirement for any specialised staff to meet study requirements (e.g. technicians, physical therapists)?
Does the site have all the equipment needed to complete the study (fridges, freezers, adequate space for secure record storage, etc)
Will all staff have the necessary training (e.g. GCP training) before study start?
4. PHARMACY DRUG AND DEVICE ADMINISTRATION
Will there be a requirement to store therapeutic goods in a location other than the site?
Will devices be used or implanted outside of the site?
Sufficient space to store IP?
Required to destroy IP on site?
5. LABORATORY PROCESSING/ANALYSIS/EVALUATION
Does the study specify Local or Central Lab testing?
Does the site have the capacity to collect all study samples at site?
Are kits and collection equipment supplied?
If we need local pathology collection and testing does an existing service agreement exist?
Do we need to obtain a new quotation and implement a new service agreement with local lab provider?
Are pathology collection times acceptable for the duration of the study? (E.g. fasting? PK etc)
Are staff suitably qualified to perform assessments or tests?
Are optional PK/PD/biobank/genotyping collection acceptable and appropriate?
6. MEDICAL IMAGING
Do imaging service providers have the capacity to perform radiographic study examinations?
Do we need to obtain a new quotation and implement a new service agreement with local imaging provider?
Are imaging test and schedule acceptable?
Does independent ionising radiation/safety report need to be conducted?
Are scans required to be uploaded to a third party vendor for central review?
Are scans to be reported using a specific system?
7. FACILITIES AND EQUIPMENT
- Weighing Scales
- Height Measurement
- -80-degree Freezer
- 2-8-degree fridge
- -20-degree freezer
- Laminar Flow Hood
8. FEASIBILITY APPROVAL
Yes/ No/ Reasons
Not Proceeding with Study? Details
1. Insufficient Budget
2. Unethical/Unable to Promote
3. Competing Study
4. Inadequate Resources
5. Lack of Appropriate Medical Coverage
6. Other – Explain