SOP 19.0 Gaining Associat~Ials v1.0 2009-08-24[1]

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SOP Number: 19.0 Version Number & Date: V1.0 25.08.2009 Superseded Version Number & Date (if applicable):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 Joint 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 Form1 (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

THIS IS A CONTROLLED DOCUMENT. UNCONTROLLED WHEN PRINTED of 3


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 Practitioner1 (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



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.


SOP 19.0 Gaining Associat~Ials v1.0 2009-08-24[1]

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