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CO-IMPACT – Standard Operating Procedures (v2)

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VersionDateIssued byApproved by
126.11.2024Constantinos ZamboglouAll Co-IMPACT PIs
2 Current13.07.2026Constantinos ZamboglouAll Co-IMPACT PIs

1. PURPOSE

This Standard Operating Procedure (SOP) describes the activities required to: Coordinate and monitor the activities of the Consortium for Implementation of PSMA-PET in Prostate Cancer therapy Trials (Co-IMPACT).

2. INTRODUCTION | SCOPE

Prostate cancer is the most prevalent malignancy among men in the Western world, and with ongoing demographic shifts, its incidence is expected to rise in the coming years. Despite advancements, optimal treatment strategies for prostate cancer remain uncertain in various clinical scenarios. To address this, the Co-IMPACT consortium was established by a global, multidisciplinary team of experts in radiotherapy, nuclear medicine, and medical oncology. Comprising 45 centers across Europe, the USA, Asia, and Australia, the consortium is dedicated to advancing prostate cancer care.

Through four sub-projects (Co-IMPACT1-4), the consortium will investigate specific clinical scenarios along the prostate cancer patient pathway. The aim is to define personalized treatment approaches and, using advanced medical imaging such as PSMA-PET/CT, improve outcomes for patients with prostate cancer.

This SOP defines the roles, the responsibilities of the consortium's principal investigators as well as the procedures ensuring a smooth operation.

3. OBJECTIVES

To define the Co-IMPACT consortium's SOPs for (i) the role of the principal investigators (PIs), (ii) the funding strategy, (iii) the authorship rules, (iv) the creation and the amendment(s) of the data transfer agreement, (v) the creation and the amendment(s) of the study protocol and (vi) the inclusion of new study centers.

4. RESPONSIBILITIES

4.1 Co-IMPACT PIs

  • The consortium consists of 16 PIs which are divided into 4 PIs per project.
  • The PIs are responsible for the strategic and operational management of the consortium.
  • All decisions require a majority vote (greater than 50% of the votes). If not all Principal Investigators (PIs) are present during a meeting, only the votes of those in attendance will be taken into account.
  • The performance of all Principal Investigators (PIs) will be evaluated annually. Should a PI no longer demonstrate active involvement, they may be excluded, requiring the approval of 75% of the voters for such a decision.

4.2 Co-IMPACT project manager

The project manager is responsible for the administrative tasks including the recruitment of new centers, the initial quality control of the clinical datasets, the organization and follow-up steps of the consortium meetings as well as the correspondence with all participants.

4.3 Data management and statistical analyses

Please see the Co-IMPACT Data Governance Policy.

5. PROCEDURES and RULES

  • All centers may submit their comments to a/the PI(s) or administrative staff.
  • The request is discussed among the PIs and with the requesting party.
  • If a majority vote favors the change, the relevant PIs will implement the modification.
  • The change is then communicated to all participating centers.

These rules apply for changes in the study protocol, the DTA and the data exchange files.

Minor adjustments may be collected and incorporated into a protocol amendment at a later stage to minimize bureaucratic overhead.

6. ABBREVIATIONS

SOP

Standard Operating Procedure

PI

Principal Investigator

DTA

Data Transfer Agreement

GDPR

General Data Protection Regulation

SAB

Statistical Advisory Board

REDCap

Research Electronic Data Capture

7. MONITORING

This SOP will be monitored and updated every two years by all Co-IMPACT PIs.

8. GUIDELINES AND REFERENCES

The Co-IMPACT consortium will follow the: