Andrew Thornton
Chairman, HREC
Royal Adelaide Hospital

> Workloads
> Additional requirements and processes due to on-line forms
> Transitioning to electronic filing by electronic submissions of all documentation.
> Additional requirements and processes due to SA Health Policies
> Issues with linking research into governance, delegations of authority, credentialing, accreditation
> National Approach (formerly HoMER).

> We are working towards making more use of electronic media and less hard copy.
> We are trying to balance the needs of SA
Health policy against the need to keep the committee functioning effectively and against the needs of researchers.
> We need everyone’s help to keep the workloads manageable and to avoid mistakes happening.

> NEAF (through on-line forms only)
> Cover letter/Investigator’s Statement (1 electronic + 2 hard copies)
> Protocol (1 electronic copy and 2 hard copies)
> Informed Consent Documents (1 electronic copy and 2 hard copies)
> Investigator’s Brochure/Product Info (1 electronic and 1 hard copy)
> IDSC Form A (1 electronic copy)
> IDSC Form B (1 electronic copy)
> Pharmaceutical Checklist (1 electronic copy)
> Questionnaires (1 electronic copy)
> Advertising material (1 electronic copy)
> Any other material (1 electronic copy)
> CTN Form (1 hard copy)
> Radiation Safety Report (1 electronic copy and 1 hard copy)
> EPA Notification Form (1 electronic copy and 1 hard copy)
> Invoicing Form (1 electronic copy and 1 hard copy)
> The submission must be complete with ALL documentation

> NEAF (through on-line forms only)
> Cover letter (1 electronic copy and 1 hard copy)
> Protocol (1 electronic copy and 1 hard copy)
> Informed Consent (1 electronic copy and 1 hard copy)
> Advertising material (1 electronic copy)
> Questionnaires (1 electronic copy)
> Any other material (1 electronic copy)
> Radiation Safety Report (1 electronic copy and 1 hard copy)
> EPA Notification Form (1 electronic copy and 1 hard copy)
> Invoicing Form (1 electronic copy and 1 hard copy)
> Any other material (1 electronic copy)
> The submission must be complete with ALL documentation.

> Check with Heather whether the study is appropriate for expedited review.
> Cover letter (1 electronic copy and 1 hard copy)
> Protocol (1 electronic copy and 1 hard copy)
> Informed Consent (1 electronic copy and 1 hard copy)
> Questionnaires (1 electronic copy)
> Advertising material (1 electronic copy)
> Any other material (1 electronic copy)
> Radiation Safety Report (1 electronic copy and 1 hard copy)
> EPA Notification form (1 electronic copy and 1 hard copy)
> There will be an on-line LNR form shortly.
> There will be an on-line LNR SSA form shortly.

> Electronic
• Request For Review Of Updated
Documentation
• Cover letter to give broad overview of reason for change and point to the detailed summary
• Summary of changes
• Amended documentation
• Detailed summary of changes including old text, new text and rationale (electronic).
> Hard Copy
• Cover letter
• Amended Information Sheet

> Electronic
• Request For Review Of Updated Documentation
• Cover letter
• Amended documentation
> Hard copy – nil
> Remember that somewhere there must be a statement from the PI to indicate whether the new information changes the risk/benefit of the study or creates any additional issues which the committee should be aware of.

> Electronic
• Request For Review Of Updated Documentation
• Cover letter
• Relevant documentation.
> Hard copy – nil
> Remember that somewhere there must be a statement from the PI to indicate whether the new information changes the risk/benefit of the study or creates any additional issues which the committee should be aware of.

> Electronic
• Cover letter
• Relevant documentation
> Hard copy - nil

> Make sure that all of the appropriate documents are submitted.
> Make sure the appropriate documents are listed in exactly the way you need them to be approved, either in a cover letter, email, or in another form such as the new “ Request For Review Of Updated
Documentation ”
> Submit the document list in MS-Word format
> Submit other documents as PDF’s which are searchable not as scanned documents.
> Use “track changes” for all document changes.
> If any submitted documents have a password, we must know what that password is.

> Submit the cover letter or cover page with scanned signatures or preferably use an electronic signature for the PI – please check that there is some control on the use of the signature
> Tell us how you are submitting, ie “electronic only” or
“hard copy to follow” (in the email, not the subject line).
> Don’t send unnecessary hard copy – it will go in the bin.
> Please don’t assume that we know what has gone on before – put the new submission in context.
> CDs should be labelled with the RAH Study Number and the PI name and submitted in SOFT covers, not hard covers.

> Subject Line – include REC # and short description of contents/documents submitted only
> In the email body (or in the “Request for Review…”)
• Full title of Protocol and REC Protocol No.
• Name and title (Mr., Ms., A/Prof, Dr) of PI
• Indication of what is to be reviewed/submitted
• List of documents submitted for review, and listed how they are to be approved.
> In the email or associated documentation, there must be contact name and return address location.
• Name: Dr Mary Smith,
• Dept: Dept of Ingrowing Toenails,
• Location: Level 1, Thornton Block.
• Phone: 8222-4139

> If there is a change to the Invoicing Details please notify us promptly of:
• Contact person
• Name of Sponsor
• Address where the Invoices are to be sent
> A new Invoice Form or the new “Request for Review of Updated Documentation” must be provided for every related study

> July 2013?
> Single ethical review
> Multiple governance reviews
> CPI responsibilities
• Submitting all documents*
• Coordinating with all sites
• Liaising with sponsor
• Preparing generic SSA
> PI responsibilities
• Preparing specific SSA
• Dealing with local RGO
* Note that we are happy with a generic Information Sheet
– provided that the text is the same at all sites, it is not necessary to submit customised Information Sheets

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