See below the full texts relating to: the Informed Consent Form, the agreements, Data reporting and Registry update. Read on.
Informed Consent Form
The adapted consent form allows patient level data to be shared with MAHs and the EMA for the sole purpose of supporting PAS studies and ultimately, regulatory decision making.
To this purpose, EBMT has amended its patient consent form (ICF) to allow patient level data to be shared with MAHs and the EMA, for the sole purpose of supporting PAS studies and ultimately, regulatory decision making. 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 has also been 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 one month of treatment or the 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 one month of treatment or the follow up visits which are expected around day 100, 6 months and then yearly for 15 years.
While the efforts to update the Registry system ProMISe are ongoing, we ask you to continue reporting data on patients with CAR-T therapies.
EBMT is in the process of replacing the Registry system ProMISe with a new Registry system. This update also impacts the collection of CAR-T data. In order to collect up to date information on cellular therapy (including CAR-T), the forms have been reviewed and updated. Data collection will now be done through 3 new forms: pre-infusion registration, day 0 and a follow-up form covering Day 100, 6 months and annual follow-up. Additionally, a new manual has been created. All documents are available on the EBMT website.
The new forms will not be implemented in ProMISe but are currently in the cellular therapy database Castor, which has been launched in June 2022. Further information about this can be found on the dedicated webpage.
If you have any questions about data reporting for the Data Collection Initiative, please contact the Clinical Study Unit by sending a mail to: EBMT_NK01@lumc.nl