Document | Where to upload till 16 Feb 2024 | Where to upload from 17 Feb 2024 |
| One electronic copy to ERM | Completed via MCC DERP – no need to upload to ERM
|
| Evidence to ERM | Upload evidence to MCC DERP |
- HREC Ethics Approval Letter
- This must list RCH or MCRI as an approved participating site.
| One electronic copy to ERM | Upload evidence to MCC DERP |
- HREC
Ethics Amendment Approval Letter(s), if applicable.
- See
IMPORTANT NOTE above for submission of additional documents.
| One electronic copy to ERM | Upload evidence to MCC DERP |
| Complete via ERM | Completed via ERM |
- Victorian
Specific Module (VSM)
| Complete via ERM | Completed via ERM |
- RCH
Participant Information Statement and Consent Form. (Tracked)
- This must
be a copy of the master PICF showing the RCH changes in tracked format.
| One electronic copy to ERM | One electronic copy to ERM |
- RCH
Parent/Guardian Information Statement and Consent Form. (Tracked)
| One electronic copy to ERM | One electronic copy to ERM |
- RCH Child
Information Sheet. (Tracked)
| One electronic copy to ERM | One electronic copy to ERM |
- Other RCH site specific documents for participants such as flyers, letters, contact
forms, advertisements, questionnaires, diaries etc. (Tracked)
- Some of these master documents may or may not need to be made site specific.
| One electronic copy to ERM | One electronic copy to ERM |
| One electronic copy to ERM | Upload to MCC DERP |
- Indemnity
(if commercially sponsored)
| One electronic copy to ERM | Upload to MCC DERP |
- Insurance
Certificate (if commercially sponsored)
| One electronic copy to ERM | Upload to MCC DERP |
- Medical
Physicists Report (both RCH and lead site). This is to be listed on the HREC
approval letter
| One electronic copy to ERM | RCH is completed in MCC DERP – no need to upload to
ERM.
Upload
MPRA from other sites to MCC DERP |
| One electronic copy to ERM | Upload to MCC DERP |
- Signatures
on the SSA form.
- Either electronically or by using the following separate
declaration forms uploaded to the SSA.
| Completed in ERM | Completed in ERM |
| One electronic copy to ERM
| Upload to MCC DERP |
- Supporting Department
Declarations completed via the MCC
Department and Ethics Research Platform are applicable for the
following departments:
- Audiology
- Cardiology
- Clinical Trials Pharmacy
- Day Medical Unit
- Endocrinology
- MCRU
- Medical Physicist Report
- Medical Imaging
- Pathology/Lab Services
- PICU
- RCH Theatres
| One electronic copy of the signed approval to ERM | Completed in MCC DERP – no need to upload to ERM |
- If there has been an ethics amendment(s) provide a zip file of ALL CURRENT versions of ethics approved documents. DO NOT INCLUDE SUPERSEDED DOCUMENTS. Label the file 'Current Ethics Set [date]'. See IMPORTANT NOTE above.
- Protocol
- Investigator's Brochure, and other product information
- Master PICFs and other participant facing documents, such as flyers, letters, contact forms, advertisements, questionnaires, diaries etc.
- Other documents as listed on ethics approval letters and any ethics amendment approval letters.
| One electronic copy to ERM | One electronic copy to ERM |