Protocol Review Committee

Chair: F. A. Shepherd, Toronto (CA)

Vice-Chair: M. Eriksson, Lund (SE)

Members:
F. Alongi, Verona (IT)
F. Baron, Liège (BE)
A. Beer, Ulm (DE)
L. Blomqvist, Stockholm (SE)
S. Bodis, Aarau (CH)
F. Brunotte, Dijon (FR)
A. Chiti, Rozzano, Milano (IT)
K. Conlon, Dublin (IR)
A.W. Craft, Newcastle-Upon-Tyne (UK)
V. Diéras, Paris (FR)
M. Guckenberger, Zurich (CH)
P.J. Goodwin, Toronto (CA)
E. Haglind, Göteborg (SE)
C. Hill, Villejuif (FR)
P. Hoskin, Northwood Middlesex (UK)
N. Isambert, Dijon (FR)
A. Jimeno, Denver (US)
S.J. Mandrekar, Rochester (US)
G. Marcucci, Duarte (CA)
S. Michiels, Villejuif (FR)
O.S. Nielsen, Aarhus (DE)
J. Oliveira, Lisboa (PT)
M. Redman, Seattle (US)
J. Rodon, Barcelona (ES)
A. Sobrero, Genova (IT)
M. Sydes, London (UK)
G. Velikova, Leeds (UK)

Phase I-II PRC Experts:
A. Elias, Aurora (US)
H.W. Hirte, Hamilton (CA)
I.R. Judson, London (GB)
P.J. O’Dwyer, Philadelphia (US)
W. Parulekar, Kingston (CA)
D. Ross Camidge, Denver (US)
L. Siu, Toronto (CA)

Ex-Officio Members:
D. Lacombe, Brussels (BE)
F. Meunier, Brussels (BE)

All protocols conducted by the EORTC need to be approved by an independent panel of experts. The Protocol Review Committee (PRC), appointed by the EORTC Board, reviews all projects proposed by EORTC Groups. The EORTC has introduced an expedited process of mutual recognition of external independent review for Intergroup projects lead by non-EORTC groups which have the prior approval of an equivalent review process, e.g. by US National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP), UNICANCER or Cancer Research UK (CRUK) Clinical Trials Awards and Advisory Committee (CTAAC).

For a study to be conducted under the EORTC label Experts must review and approve the project. This is done by the PRC. In addition, the database should be handled by EORTC Headquarters (HQ) staff and the final analysis should be performed by an EORTC statistician unless conducted by another independent research group in the context of a so-called intergroup clinical trial.

The PRC comprises experts in the field of cancer clinical research. All disciplines of oncology are represented in the review panel. About 50% of the PRC members are non-EORTC members, and selected projects are reviewed by a representative of the NCI CTEP. Additionally, the PRC makes systematic use of external reviewers – a minimum of three international experts are consulted for each outline thereby providing independent review.

The Protocol Development Unit (PDU) follows the overall protocol development and approval process. Full protocols must be a faithful development of approved outlines. Significant modifications of the study outline after its approval will need to be approved again by the PRC. If the modifications have an impact on the resources to be allocated by the EORTC, the decision of the EORTC Board to have the study supported by the EORTC may be reconsidered. After a protocol is approved and released any change is deemed an amendment. The PRC approves scientific amendments to EORTC protocols and the PDU coordinates their implementation into protocols.

All efforts are made to speed up the review process in order to activate protocols quickly, but the PRC must make sure that all studies with the EORTC label are conducted according to the highest possible standards (scientific, administrative and regulatory) of clinical scientific investigation. The Translational Research Advisory Committee (TRAC) including imaging and the Cancer in the Elderly Task Force provide additional scientific expertise when needed.

Full Protocol Submission

Full protocols are developed in a modular way with the logistical support of the EORTC Protocol Document Manager/Associate and the HQ team. Appropriate instructions, guidelines, and templates will be addressed to the Study Coordinator by the PDU shortly after outline approval.

When the final version of the full protocol is available, the Study Coordinator in collaboration with the HQ team should send a submission letter (or e-mail) which includes the description of eventual differences between the accepted outline and the full protocol to the PDU.

The final protocol version will be subject to an internal revision process within the HQ to check adherence with the PRC approved outline, compliance with EORTC Policies and with EORTC Standard Operating Procedures, and to detect eventual discrepancies or inconsistencies that might affect the conduct and/or the management of the study. In case of major discrepancies with the original outline and/or irresolvable disagreement with the internal reviewers, the protocol will be resubmitted to the PRC.

All Study Coordinators need to complete a conflict of interest form according to the EORTC Conflict of Interest and Confidentiality Policy and sign the document entitled ‘Tasks & responsibilities of Study Coordinators’. Both documents are sent to the Study Coordinator at the time of outline approval and

must be signed before submission of the full protocol.

Intergroup Studies

Intergroup studies should follow the EORTC Intergroup Policy. If the trial is coordinated by an EORTC Group or HQ, EORTC approval will be obtained through the usual submission procedure (see above). If the EORTC is neither the Coordinating Group nor the Coordinating data center, the EORTC Group(s) should appoint an ‘EORTC Coordinator’ who will complete an outline questionnaire (even if the full protocol is already available) and send to the PDU a copy of all available documentation of prior peer reviews of the project (preferably as digital versions). If the study is already active in another group, the reasons why the EORTC will join the trial at a late stage should be explained in the comment section of the outline questionnaire. If the full protocol is already finalized, it should be sent to the PDU at the time of outline submission. If the group specific appendix (GSA) is already finalized and approved by the EORTC International Policy Office, the PDU should be informed. Development of the full protocol is normally the responsibility of the Coordinating Group. HQ will develop a GSA. Further review process will be decided by the PRC on the basis of the information provided at the time of outline submission.

Amendments

After PRC approval, any modifications to the protocol, patient information sheet and informed consent document (PIS/IC) or GSA must be discussed and subsequently submitted to the PRC, as appropriate. The changes will be reviewed, approved and implemented in the protocol, and a new version will be issued. HQ will make new versions available on the web site, circulate the amendment and the new version of the protocol to all investigators, and will inform health authorities and ethics committees when needed.

All documents and correspondence should be addressed to the EORTC Protocol Development Unit (PDU)::
protocols@eortc.be

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