Set-up of the Data Collection Initiative to support the PAS studies

The adapted consent form allows patient level data to be shared with EBMT’s Collaboration partners, such as MAHs and the EMA for the sole purpose of supporting PAS studies and ultimately, regulatory decision making.

EBMT has amended its patient consent form (ICF) to allow patients to choose to share their pseudonymised data with EBMT’s collaboration partners, for example MAHs for research purposes. This means that there will be no separate ICF for individual PAS studies, but a general informed consent form that can be used to support PAS studies for currently available as well as future CAR-T therapies. Until this ICF is approved by the applicable regulatory authorities and the patient has (re)consented, data will be shared only in aggregate reports.

This new ICF was also implemented in May 2022 for all Registry patients.

To participate in the Data Collection Initiative a centre must sign the Data Collection Master Agreement and a Product-Specific Agreement. In addition, all EBMT centres should sign a Joint Controllership Agreement.

The contracts for the Data Collection Initiative on CAR-T are split in two parts. The Data Collection Master Agreement governs the general data collection requirements that are identical for all CAR-T therapies. Whereas the short Product-Specific Agreements specify additional requirements for the individual CAR-T therapies. For each new PAS study, you will only need to sign a new Product-Specific Agreement. 

We also remind your centre to sign the Joint Controllership Agreement (JCA), which stipulates that all data processing is done in compliance with the GDPR. This document governs all data processing activities between EBMT and the centre and is thus a prerequisite but not specific for the PAS studies. The JCA should be signed by all centres, including those who do not participate in the Data Collection Initiative on patients treated with CAR-T.

Report data on all patients treated with CAR-T therapy within six weeks of treatment or any follow-up visits.

Data collection per the regular data collection forms and procedures does not require additional contracts and regulatory approvals. We thus ask you to report data on all patients treated with CAR-T therapy within six weeks of treatment or any follow-up visits which are expected around day 100, 6 months and then yearly for 15 years.

All relevant data should be reported in the new EBMT Registry using the new Data collection forms.