Health CALHN User Manual

Guidelines for Submissions
(Agreement s and Site Specif ic Assessment s)

Overview

These guidelines will provide CALHN Clinical Trial Units with the necessary information to submit agreements and site­specific assessments for review by CALHN Research Services.

Contracts

• All Clinical Trial related agreements are to be sent to the following email address:
o [e-mail]

• Note: Do not send (or cc in) any agreement directly to CALHN Research Services staff members. The generic

email address provided above is actively monitored, categorised, reviewed and actione d.

• Do not copy in CALHN Res earch Services personal e mail addresses’ to introd uce or action a request with a

sponsor or external party.

• Fees & Invoicing Information: Please ensure you send the Sponsor/Local Sp onsor a copy of the CALHN

Invoicing Fee Form (Ethics & Governance) available for download here
Governance Fee Schedule available here. Note: T he IT/Software Fee is on ly visi ble on the invoici ng fee form
as it is a CALHN specific fee and not yet available on the SA Health Fee Schedule.

New Clinical Trial Research Agreements:

• For a Clinical Trial Research Agreement to be reviewed, submit the following listed documents:

o Clinical Trial Research Agreement – in word versi on
o Excel Budget Spreadsheet – if this has been provided
o Standard Form of Indemnity (except CRG’s and non-medicines Australia agreements)
o HREC Review onl y Indemnity – (only required if a multi-site study where CALHN is the Reviewing

HREC)

o Quotes – Pharmacy, Imaging, Radiology, Pathology – If applicable
o Copy of the Protocol

• If this information is not provided, a request for further information will be sent back.

and the SA Health Research Ethics and

Amendments to Clinical Trial Research Agreements:

• For Amendments to the Clinical Trial Research Agreement, submit the following documents:

o Amendment/Variation agreement in word version
o HREC approval letter – if related to protocol amendment or change of PI
o Quotes – if adding any services not previously included

Novation Agreements:

• Where a party is being replaced (e.g. Sponsor / Local Sponsor) a novation agreement is required.

• Please provide the following:

o Novation agreement in word version
o Effective date of change to new party
o HREC acknowledge/approval of change of sponsor

Confidentiality/Non-Disclosure Agreements:

• For Confidentiality/Non-Disclosure Agreements, provide the following:

o Contract in word version
o Name of PI who will be undertaking feasibility (unless master/non-study specific agreement)

Master Services Agreements:

• If you require the serv ices of an externa l pro vider ther e m ust be a s ervices agr eem ent in place in ord er to pa y

for the services, as this is a treasury requirement.

• Provide the following information:

o Name and address of entity/business/trading name of service pro vider
o ABN

Enquiries to [e-mail] or 08 7117 2231

CALHN Research Services| Guidelines for Submissions (Agreements & Site Specific Assessments)

Version 1.0 I March 2021 I Page 1 of 3

o Address and contact for notices

Project Title

XXX

Protocol:

XX

Principal Investigator:

XX

Program Directory:

RAH/TQEH: XXXX: XXXXX

HREC Reference Number:

202X/HREXXXXX / or External HREC Number

SSA Reference Number:

202X/SSAXXXXX

CALHN Reference Number:

MYIPXXXXX

o Phone number and contact email address of service provider
o Insurance Certificate (Clinical trials or Medical Indemnity Insurance)

• Note: the work order template in schedule 1 of the Master Services Agreement is not to be signed, as it is only

a template which must remain within the document.

Work Orders

• Provide the following information:

o Study details (e.g. title, protocol number, Sponsor, MYIP)
o Term of services (commencement and expiration date)
o Protocol Requirement for Clinical Services (state relevant section of protocol)
o List of services being provided
o Fees of the service provided (and state whether they are GST free, inclusive or exclusive)

Site Specific Assessments

• All Site Specific Assessments are to be completed via Research GEMS available here.

• For guidance in c reating a Sit e Specific Asses sment Applicat ion, visit th e RAH websit e for more infor mation,

located here
Guidelines”.

• External HREC - Once th e Reviewing HREC has appr oved the study, you will be able to s ubm it your SS A via

GEMS.

• CALHN HREC – You can submit the Site Specific Assessment Application, however the status will not be

‘Eligible’ until HREC approval has been obtained.

• Research GEMS requires the following documents to be uploaded as a minimum on all Site Specific

Assessment Applications:

o HREC Approval letter
o HREA
o Protocol

• All study documentation ( as listed i n the check list) can be uplo aded either into Resear ch GEMS in t he upload

section or in the relevant Clinical Trial Unit sub-folder on the Share Drive. Indicate which method has been used
in your submission email.

• Once submitting your application via Research GEMS, please send an email to

[e-mail]

and download the “CALHN Clinical Trial GEMS Project Registration and SSA Submission

in the following format:

Dear CALHN Research Services,

<Clinical Trial Unit Name> has now submitted an SSA for the below study:

*indicate whether you have uploaded via GEMS or Share Drive
Thanks

<email signature>

Enquiries to [e-mail] or 08 7117 2231

CALHN Research Services| Guidelines for Submissions (Agreements & Site Specific Assessments)

Version 1.0 I March 2021 I Page 2 of 3