Western Health Name Change and Site Relocation Submission Requirements​

Updated memo from Prof Edward Janus, Director of Research, Office for Research: Memo OfR ​ResearchGovernance NameChangeRelocation 11Feb15.pdf

Name Change

Western Hospital changed their site name to Footscray Hospital, effective 01 October 2014.

Please disregard the previous grace period requirements for submitting documentation regarding the name change. Researchers/sponsors are now advised to submit revised documents (for name change) the next time you make any amendments to your project.

The Approving Authority and Institution name remain Western Health and address remains unchanged.

We confirm that the name change has no legal implications for clinical research activity at Footscray Hospital as noted in the Letter sent by the Chief Executive (Alex Cockram) dated 30 October 2014 which explains the change and confirms the legal stance. ​Memo Name Change 30Oct14 Alex Cockram

Please note this name change does affect Research Governance, specifically the Clinical Trial Notification (CTN) Forms, and Western Hospital site specific Participant Information and Consent Forms (PICFs) for currently open studies – timeframe as above.

The following documents may be required for submission depending on the particulars of your trial:

Human Research Ethics Committee (HREC) acknowledgement

• Please submit a cover letter indicating the site name change including the trial name, number and PI to the Reviewing HREC and follow any advice provided by them.
• If you are part of a multi-site trial you may need to work via the Lead Site to communicate with the Reviewing HREC.
• Please request acknowledgement from the Reviewing HREC for your correspondence.

• The Therapeutic Goods Administration (TGA) requires written confirmation of the name change for any trial requiring ongoing exemption to administer an unapproved drug therapy. As the Approving Authority and physical location of the Investigational Product has not changed, researchers/sponsors are not required to resubmit the full CTN; you are only required to provide an updated single 'Page 5' listing the updated site name (no change to address) and an updated 'Page 9' Approving Authority Page signed by Western Health.
• If your trial no longer administers the unapproved therapy you are not required to provide any updated CTN pages
• Please use the latest version of the CTN dated July 2014. 

• Please submit a cover letter indicating the trial name, number and Principal Investigator (PI), a copy of the HREC acknowledgement, and a Page 5 and Page 9 of the CTN (if applicable) to the WH Office for Research. Submissions without CTNs are to be made electronically. Submissions with CTNs must be made in hard copy to facilitate signature authorisation.
• WH Office for Research will provide acknowledgement and return CTN pages, if applicable.
• Please provide an Express Post envelope if you wish the pages to be returned to you via Express Post. You may also pick up the signed documents from the Office for Research when informed that they are ready.
• Administrative amendment fees will not be charged by the WH Office for Research for the name change.
• For trials with updated CTNs, the HREC acknowledgement, Research Governance acknowledgement and CTN pages (with original Page 9 signature) should be lodged with a cover letter to the TGA indicating the name change and a contact person for queries - see the front page of the CTN form lodgement address
• A TGA lodgement fee is NOT applicable for the name change.
• This action should be taken as soon as possible

• In order to decrease burden of re-consent revised PICFs are not required until the next amendment to your project. However, participants who have already consented should be verbally advised of the name change at their next visit and this should be documented in their notes for monitoring purposes.
• When revised PICFs are revised at the next amendment to your project, new participants will need to sign these.
• Alternatively, researchers are able to facilitate updated PICFs earlier than this, if sponsors prefer.
• No administrative amendment fees will be charged (for PICF update to site name only) by the WH Office for Research.

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Relocation

Please disregard the previous grace period requirements for relocation times. Researchers or sponsors are advised to submit revised documents to the Office for Research when relocation has been confirmed or established.

We confirm that the re-location has no insurance and indemnity legal implications for continuing clinical research activity for departments relocating to Sunshine Hospital, the following insurance and indemnity policies are not affected:

• Medical Indemnity
• Professional Indemnity
• Public and Products Liability
• Directors and Officers Liability
• Industrial Special Risks (which includes Property)

This relocation affects Human Research Ethics Committees (HRECs), Research Governance, Clinical Trial Research Agreements (CTRAs), Clinical Trial Notification (CTN) Forms, and Western Hospital site specific Participant Information and Consent Forms (PICFs) for currently open studies.

The following documents may be required for submission depending on the particulars of your trial:

Clinical Trial Notification (CTN) Forms

• The Therapeutic Goods Administration (TGA) requires an updated CTN for any trial requiring ongoing exemption to administer an unapproved drug therapy. If the physical location of the Investigational Product will change, researchers/sponsors are required to resubmit the full CTN listing the new location and lodgement fees will be payable.
• If trial activity is to commence at an additional location (activity at both Footscray and Sunshine) researchers/sponsors are required to resubmit the full CTN listing the composite site and lodgement fees will be payable
• Please use the latest version of the CTN dated July 2014.
• If your trial no longer administers the unapproved therapy and may or may not have patients in long term follow up, you are not required to provide any updated CTN pages to the TGA however a Trial Completion Advice for the site should be sent by the Sponsor to the TGA.
• NOTE: The TGA is aware that trial may relocate and out of necessity, supply patients prior to notification to the TGA due to logistical issues. While this is not ideal, it is understood on this occasion provided that the signatories are aware that conducting trial related activities at a site which is not notified at the time of supply of the unapproved goods may be a breach of the conditions of the CTN exemption. However, TGA would not act on such a breach given the circumstances and are simply making everyone aware. This situation may be logistically unavoidable and the TGA understand that it is in the best interests of the patients that the supply of medicines is not ceased.
• If the trial is to be open at both Footscray Hospital and Sunshine Hospital simultaneously, activity at Sunshine Hospital should not commence until TGA acknowledgement is available, as there is already an approved location for trial activity for WH participants.

• HREC Amendment Approval from the Reviewing HREC is required for addition of a composite study site.
• If the trial requires ongoing exemption to administer an unapproved drug therapy then a new CTN must be signed by the Reviewing HREC and must list both sites on separate Page 5 sheets, and also have 2 copies of Page 9 Approving Authority
• Please submit the Amendment Form and CTN if applicable to the Reviewing HREC and follow any advice they provide
• HREC Amendment fees may be applicable
• If you are part of a multi-site trial you may need to work via the Lead Site to communicate with the Reviewing HREC
• If applicable, for studies where name change is also applicable, a once off amendment can be submitted to decrease administrative workload by combining the name change and relocation submission together.
   
• HREC acknowledgement (or approval per specific HREC processes) from the Reviewing HREC is required to confirm awareness of the location change
• If the trial requires ongoing exemption to administer an unapproved drug therapy then a new CTN listing the updated site location must be signed by the Reviewing HREC
• Some HRECs will require an Amendment, some will accept a Correspondence letter.
• Please submit the required documentation to the Reviewing HREC and follow any advice provided by them.
• If you are part of a multi-site trial you may need to work via the Lead Site to communicate with the Reviewing HREC
• Please request Acknowledgement from the Reviewing HREC for your correspondence or an Approval Letter.

• Please submit a cover letter indicating the trial name, number and PI, a copy of the HREC acknowledgement, CTN if applicable, to the WH Office for Research.
• Submissions without CTNs are to be made electronically. Submissions with CTNs must be made in hard copy
• WH Office for Research will provide acknowledgement and return CTN pages if applicable
• Please provide an Express Post envelope if you wish the pages to be returned to you via Express Post. You may also pick up the signed documents from the Office for Research when informed that they are ready.
• ​Administrative amendment fees will not be charged by the WH Office for Research
  
• For trials with updated CTNs, the HREC acknowledgement, Research Governance acknowledgement and CTN pages (with original Page 9 signature/s) should be lodged with a cover letter to the TGA indicating the name change and a contact person for queries - see the front page of the CTN form lodgement address
• A TGA lodgement fee will be applicable

• In order to decrease burden of re-consent Revised PICFs are not required until next Amendment. However, participants should be verbally advised of the relocation or composite site (if relevant to the participant) at their next visit and this should be documented in their notes for monitoring purposes
• When revised PICFs are revised at the next amendment to your project, new participants will need to sign these.
• Alternatively, researchers are able to facilitate updated PICFs earlier than this, if sponsors prefer.
• No administrative amendment fees will be charged (for PICF update to site name only) by the WH Office for Research.

• Leah Biffin (WH Medical Physicist) has provided a letter indicating that Radiation Safety Reports and Victorian Specific Module section 4 will remain valid across any Western Health location.​

​Thank you for your patience and understanding through the new changes occurring at Western Health.​

HAVE ANY QUESTIONS?

We appreciate that these changes may generate further questions. Please feel free to contact the Office for Research on 8395 8074 or at [email protected]. 

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