CHQ HREC Full NEAF Checklist for Researchers Yes No No. of No. Description Please Please Copies Tick Tick 1 Covering letter signed by Principal Investigator. 12 2 Parent/Guardian Information and Consent Forms. 12 3 Child/Adolescent Information and Consent Forms. 12 Questionnaires, advertisements, diaries, product information and other 4 12 documents to be used in the study. Are the Information Sheet and Consent Forms prepared according to the Researchers Guidelines? (On institutional letterhead, full title on both the 5 Information Sheet and the Consent Form, contact details for HREC, provision for signature of witness) National Ethics Application Form 6 Has this been submitted through On-Line forms website Has the form 12 – been locked? 7 Victorian Specific Module (for applications to be reviewed under MOU). 12 Do all documents contain version numbers, version dates and page 8 numbers? 9 Investigator’s Brochure where applicable. 1 10 CTN/CTX form where applicable. 1 11 Clinical Trial Agreement where applicable. 1 Indemnity Form consistent with Medicines Australia guidelines 12 1 appropriate. 13 Current insurance certificate where appropriate. 1 Letter of support from RCH sponsor for external researchers wishing to 14 1 conduct research within the hospital. Letter of approval from Director of the Department in which the research 15 1 will be conducted. Statement regarding submission to other HRECs and status of those 16 1 submissions. For student researchers working towards a higher degree, name, address 17 1 and signature of supervisor must be supplied. For external researchers, has provision been made for initial contact with 18 potential participants to be made by the treating physician or therapist?
CHQ HREC Full NEAF Checklist for Researchers No. Description No. of Copies Yes Please Tick No Please Tick 1 Covering letter signed by Principal Investigator. 12 2 Parent/Guardian Information and Consent Forms. 12 3 Child/Adolescent Information and Consent Forms. 12 4 Questionnaires, advertisements, diaries, product information and other documents to be used in the study. 12 5 Are the Information Sheet and Consent Forms prepared according to the Researchers Guidelines? (On institutional letterhead, full title on both the Information Sheet and the Consent Form, contact details for HREC, provision for signature of witness) 6 National Ethics Application Form Has this been submitted through On-Line forms website – Has the form been locked? 12 7 Victorian Specific Module (for applications to be reviewed under MOU). 12 8 Do all documents contain version numbers, version dates and page numbers? 9 Investigator’s Brochure where applicable. 1 10 CTN/CTX form where applicable. 1 11 Clinical Trial Agreement where applicable. 1 12 Indemnity Form consistent with Medicines Australia guidelines appropriate. 1 13 Current insurance certificate where appropriate. 1 14 Letter of support from RCH sponsor for external researchers wishing to conduct research within the hospital. 1 15 Letter of approval from Director of the Department in which the research will be conducted. 1 16 Statement regarding submission to other HRECs and status of those submissions. 1 17 For student researchers working towards a higher degree, name, address and signature of supervisor must be supplied. 1 18 For external researchers, has provision been made for initial contact with potential participants to be made by the treating physician or therapist?
chq-hrec-neaf-cl.docx