Tracked and clean versions Must have version/date Site Specific details entered (SA Health Logo, PI/Coordinator details and local complaints details) Site Specific details entered (SA Health Logo, local PI/Coordinator details and local complaints details) Tracked and clean versions Must have version/date Site Specific PISCF Must have version/date Studies involving radiation: Site specific PICF must include radiation safety wording Covering letter to state site and participant impact that mirrors report approved by HREC) Studies involving radiation: Site specific PICF must include radiation safety wording that mirrors report approved by HREC). Updates are required if protocol amendment results in changes to radiation assessments and hence change in dose. E.G. Radiation Safety Must be on HREC approval letter increase in frequency in MUGA scans for safety or CT for Report/Standard of efficacy. Care declaration by Attach declaration/report PI Must be on HREC approval letter Attach declaration/report Must be on HREC approval letter Must be on HREC approval letter Must have version/date Must have version/date Advertising All radio advertising must receive approval from Media & All radio advertising must receive approval from Media & Communications Communications Legal Documentation Insurance From Third Party Sponsor/University/Employer outside of SA From Third Party Sponsor/University/Employer outside of SA Health, must be current Certificate Health, must be current Medicines Australia 3x Originals partially executed by Sponsor and PI 3x Original amendments partially executed by Sponsor and PI Clinical Trial Must include correct Institution details (see bottom of form) Must include correct Institution details (see bottom of form) Agreement Covering letter must state reason for amendment
Tracked and clean versions Must have version/date Site Specific PISCF Site Specific details entered (SA Health Logo, local PI/Coordinator details and local complaints details) Must have version/date Studies involving radiation: Site specific PICF must include radiation safety wording that mirrors report approved by HREC) Site Specific details entered (SA Health Logo, PI/Coordinator details and local complaints details) Tracked and clean versions Must have version/date Covering letter to state site and participant impact Studies involving radiation: Site specific PICF must include radiation safety wording that mirrors report approved by HREC). Radiation Safety Report/Standard of Care declaration by PI Must be on HREC approval letter Attach declaration/report Updates are required if protocol amendment results in changes to radiation assessments and hence change in dose. E.G. increase in frequency in MUGA scans for safety or CT for efficacy. Must be on HREC approval letter Attach declaration/report Advertising Must be on HREC approval letter Must have version/date All radio advertising must receive approval from Media & Communications Must be on HREC approval letter Must have version/date All radio advertising must receive approval from Media & Communications Legal Documentation Insurance Certificate From Third Party Sponsor/University/Employer outside of SA Health, must be current From Third Party Sponsor/University/Employer outside of SA Health, must be current Medicines Australia Clinical Trial Agreement 3x Originals partially executed by Sponsor and PI Must include correct Institution details (see bottom of form) 3x Original amendments partially executed by Sponsor and PI Must include correct Institution details (see bottom of form) Covering letter must state reason for amendment