MATER HEALTH SERVICES Human Research Ethics Committee INITIAL SERIOUS Adverse Event (SAE) Report This information refers to SAE / SUSAR REPORTS RELATED to sites under the Mater Health Services HREC approval. A cover letter / cover sheet is not required. MHS HREC Ref No Title of protocol: Protocol version Participant Information Sheet & No.& Date: Consent Form Version no. and Date: Study drug/s / device: Principal Investigator/s: Date of Date participant Enrolment adverse event: commenced on study: Number: Date of report: Gender: F M DOB: Was Informed Consent obtained: Yes No Event: Description of event:
MATER HEALTH SERVICES Human Research Ethics Committee INITIAL SERIOUS Adverse Event (SAE) Report This information refers to SAE / SUSAR REPORTS RELATED to sites under the Mater Health Services HREC approval. A cover letter / cover sheet is not required. MHS HREC Ref No Title of protocol: Protocol version No.& Date: Participant Information Sheet & Consent Form Version no. and Date: Study drug/s / device: Principal Investigator/s: Date of adverse event: Date participant commenced on study: Enrolment Number: Date of report: Gender: F M DOB: Was Informed Consent obtained: Yes No Event: Description of event:
Initial-Serious-Adverse-Event-Form-V3-08062016.docx