GAINING ASSOCIATED SUPPORT SERVICES APPROVAL FOR CLINICAL TRIALS

V1.0 25.08.2009

Kent and Medway Cancer Research Network

Standard Operating Procedure:

GAINING ASSOCIATED SUPPORT SERVICES APPROVAL FOR
CLINICAL TRIALS
SOP Number: 19.0
Version Number & Date: V1.0 25.08.2009
Superseded Version Number & Date (if applicable):
Effective Date: 25.08.2009

Review Date: 24.08.2011

Author:
Name: Dr Barbara Mercier 25.08.2009
Position: KMCRN Manager Signature Date

Approved by:
Name: Dr Mark Hill 25.08.2009
J oint Clinical Lead for Research Signature Date

Name: Position:
Signature Date

BACKGROUND
A significant number of clinical trials on the Kent and Medway Cancer Research Network
(KMCRN) portfolio involve service support departments, for example diagnostics such as
pathology, radiology etc. These departments should arrange for an appropriate person to review
the clinical trial protocol and agree to support the trial. KMCRN has established a Trial Feasibility
Form
1
(TFF) (SOP 21.0: Identifying the Additional Resources Required to run a Clinical Trial) for
completion by the associated departments. In order to comply with Research Governance, It is
important that any support department involved in a trial is fully aware of the trial and has agreed to
provide the support required, as dictated by the protocol. Sometimes the trial will require additional
tests over and above standard; the DH will meet these costs through funding to the
Comprehensive Local Research Network (CLRN). Occasionally the trial will require additional
tests or treatments, which are defined as Excess Treatment Costs (Attributing revenue costs of
externally-funded non-commercial research in the NHS (ARCO): Gateway ref 5956, December
2005; HSG(97)32: Responsibilities for meeting patient care costs associated with Research and
Development in the NHS). KMCRN has established a process to commission Excess Treatment
Costs associated with trials on its portfolio (SOP 36.0: Process for Commissioning Excess
Treatment Costs in Cancer Clinical Trials)

The Principal Investigator or a Co-Investigator will identify both Service Support and Excess
Treatment elements of each trial prior to sending the TFF to the support department.

Approval for chemotherapy and pharmacy associated activity is addressed by additional Standard
Operating Procedures (SOP 16.0: Gaining Pharmacy Approval for Clinical Trials; SOP 20.0:
Gaining Chemotherapy Service Approval for Clinical Trials).

PURPOSE
To describe the procedure for gaining approval from support departments for work associated with
a clinical trial.

1
The term trial feasibility form may apply to any form specified by local Trust R&D Department, since forms are subject to change
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GAINING ASSOCIATED SUPPORT SERVICES APPROVAL FOR CLINICAL TRIALS
V1.0 25.08.2009

PROCEDURE

1. WHO?
1.1 It is the responsibility of the Principal Investigator (P.I.) or his/her delegated staff member to
ensure that all necessary service support approvals are in place prior to initiating the
clinical trial.

1.2 It is the responsibility of the nominated Clinical Trials Practitioner
1
(CTP) to ensure that
initial approvals are in place for any required clinical trial service support, prior to initiating
ethics or Trust R&D approval.

2. WHEN?
The KMCRN Research and Trials Group (RAT) must first agree to include a clinical trial on the
KMCRN portfolio. A nominated member of the group will complete the generic sections of a TFF.
The TFF will then be shared with interested research teams in the KMCRN. The research team will
agree whether to take part in the clinical trial; this decision will be made initially by the Senior CTP
and Clinician(s) based on staff capacity in the frontline team. If the trial is agreed approval will be
sought from the relevant service support departments.

3. HOW?
3.1 The Senior CTP (or designated staff member) will forward a copy of the protocol, plus the
relevant sections of the TFF (SOP 21.0: Identifying the additional resources required to run a
clinical trial) to the lead in each support service department with a covering letter if required
(Appendix A).

3.2 The service support department will confirm agreement to the Senior CTP.

3.3 In event of non-agreement the Senior CTP will inform the Kent and Medway Cancer
Research Network Manager, who will escalate the decision to the appropriate Research and
Trials Group Chairperson and, if the non agreement is due to insufficient support service
funding, to the CLRN Senior Manager.

4. OTHER RELATED PROCEDURES
SOP 16.0 Gaining Pharmacy Approval for Clinical Trials
SOP 18.0 Conducting a Research Study: Overview of Process
SOP 20.0 Gaining Chemotherapy Service Approval for Clinical Trials
SOP 21.0 Identifying the Additional Resources Required to run a Clinical Trial
SOP 36.0 Process for Commissioning Excess Treatment Costs in Cancer Clinical Trials

5. APPENDICES
Appendix A Template Letter to Support Services Department





1
The title Clinical Trials Practitioner is interchangeable with the alternative titles of Research Nurse or Clinical Trials Coordinator
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GAINING ASSOCIATED SUPPORT SERVICES APPROVAL FOR CLINICAL TRIALS
V1.0 25.08.2009



APPENDIX A

<Insert local Research Office address>



<Insert Date>

<Insert name and address of local contact>


Dear <Insert name>
RE: <Insert Trial Acronym, full title and version number>
Please find enclosed a copy of the protocol and a Trial Feasibility Form for the above clinical trial
which we are planning to open at <insert hospital name>.
Please retain the protocol for your own use.
If you have any queries regarding the protocol, I would be grateful; if you could raise these within
three weeks of receipt to the Research Office by email or internal post.
Prior to the trial opening, a member of the Research Team will deliver a training session if
required.
Please confirm (by email, telephone or letter) that you are able to support this study.
Thank you for your support.
Kind regards.
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