Prior to the WP review, an estimated budget for the running costs of the study should be requested from the PCTC administrator for consideration. Potential sources of funding should also be identified. No study should be submitted for PCTC review without prior sign-off from the relevant WP.

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Protocol and Resource Review

Once accepted by a working party and signed off by the WP Chair, the study proposal should be submitted to the PCTC Administrator, who will distribute it to the PCTC for an initial review. 
New proposals will be reviewed in order of receipt, unless otherwise advised by the Board. To maximise flexibility for the working parties the cut-off date for acceptance for review for the January Meeting will be the 15^th November and for the June Meeting the 15^th April.
The PCTC will review and prioritise and present its recommendations on ALL protocols submitted to the Board at the January and June Board meetings.

To minimise waste of resources, the protocol, for PCTC review, should, be limited to the following elements:

• Brief overview of study rationale
• Study design
• Objectives
• Eligibility Criteria
• Treatment Plan
• Summary of data to be collected
• Statistical plan, in particular sample size (written by a statistician)
• Estimated budget

Reviewers will be selected from amongst the current “pool” of PCTC reviewers.  There should be a minimum of three reviewers; two should be clinicians and one a statistician. The review should be completed within 2 weeks and any comments discussed with the Coordinating P. All reviewers must be independent of the study.
In parallel the PCTC Administration will liaise with the Coordinating PI on financial negotiations with the potential sponsor(s) or funding organisations. For studies with no source of funding the PCTC will review current staffing and/or potential to support study from existing infrastructure.
PCTC Administrator to collate reviews/recommendations and distribute the Prioritisation Committee of the PCTC and coordinate a conference call to discuss reviews. A further conference call will be arranged to discuss recommendations for prioritisation of all submitted proposals in relation to its relevance and scientific importance to the pan EBMT research strategy; in advance of the January and June Board Meetings. At the January and June Board meetings the PCTC Chair will present a review of all protocols reviewed and the recommendations of the PCTC in relation to acceptance or rejection and the prioritisation order of protocols.
If the trial is adopted as an official EBMT protocol, then  after the scientific elements of the protocol have been completed, all the administrative elements, to make it ICH-GCP compliant etc., will be added by PCTC/CTO administrative staff, later on in the process.

Acceptance or rejection of a protocol will be decided by the Board. If accepted then the protocol will be signed off by the WP Chair, PCTC Committee on behalf of the EBMT.

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Initiation of EBMT Sponsored Protocols

After acceptance as an EBMT sponsored study the Administrative staff of the PCTC with assist the Coordinating PI to finalise the protocol and prepare to submit for Regulatory and Ethical approvals. This should be completed within 2 months. In case of possible multiple protocols they will be processed in parallel, where possible. Alternatively they will be selected in order of priority.

Preparation and completion of a protocol includes:

• Draft protocol revised to be EU Directive/ICH-GCP compliant, draft sample PIL, send back to steering committee +/- sponsors (Clinical Trials Office (CTO))
• Registered on EUdraCT database, allocated EBMT protocol number (CTO)
• Registration on WHO approved Clinical Trials Registry
• CTO to assemble all documents required for regulatory submission confidentiality agreement (s ), prepare English version of Clinical Trial Authorisation (CTA) application, Investigator Brochure, Summary of Medicinal Product Characteristics (SMPC), letter of cross reference etc
• Site selection, (Consider numbers of eligible patients/annum, institutional resources and previous accrual/quality assurance (QA) info on centres)
• Identify Country PIs
• Progress contract negotiations as relevant (CTO in liaison with PI)

EBMT <-> Sponsor

EBMT <-> Institution

EBMT <-> Other e.g. supply Clinical Research Organisation (CRO) if relevant

(NB ensure salary lines and all infra-structural costs are on a timeline dependent not accrual related payment schedule)

• Finalise protocol and distribute to relevant parties for sign-off
• Arrange insurance policies for participating countries
• Distribute protocol for submission to ethics and Competent Authorities (CAs) as relevant
• Draft Case Record Forms (CRFs) /build database, send for review, finalise and sign-off
• Initiation plan/monitoring plan
• Drug distribution plan if relevant

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 Audit

The PCTC will oversee the quality assurance audit programme of the EBMT.  The PCTC should develop an audit plan, defining what should be audited and oversee the execution of the audit. Subsequently they should evaluate the audit report, notify the unit of the results of the audit and ensure any deficits or action points are addressed.

In addition it will also keep abreast of any new legislation to ensure the group can respond promptly to any change in legislation. Standard Operating Procedures (SOPs) developed to documents all procedures related to study conduct should be reviewed and signed off by the Chair of the PCTC and the Director, Clinical Trials Operations. All existing SOPs should be reviewed for relevance by the committee on an annual basis.

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Liaison with the Pharmaceutical Industry

The EBMT need to strengthen ties with the Pharmaceutical Industry; to ensure that the group have access to new compounds. Any investigator, who intends to approach a pharmaceutical company regarding ongoing and/or planned EBMT trials, should notify the PCTC of their intent, as soon as possible, to ensure that duplicate or conflicting approaches are avoided. The PCTC should closely monitor the progress of Pharmaceutical Company Studies to ensure that the EBMT are meeting their obligations.

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Source Funding Opportunities

The PCTC should source grant programmes and submit proposals to consolidate and build the clinical trials support infrastructure. There is an urgent need to put a clinical trials database in place and significant funding must be sourced to finance such a move. Additional funding is also required to expand the pool of monitors employed by the EBMT and data managers etc, in particular to increase the support for non-funded studies.

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