Publication Policy

This policy describes the steps required to request statistical output or data for publication purposes using ECRI trials’ databases. It is responsibility of the Sponsor (ECRI) to maintain integrity of trial databases and to oversee the publication strategy and process safeguarding the interests of stakeholders, which include priority, relevance, scientific value and novelty. Under no circumstances a submission will be halted based on unfavourable results. ECRI will enforce agreements with grant-givers allowing them to review manuscripts in order to protect IP.

This policy applies to individuals or organizations who wish to use data collected in ECRI trials' databases. This policy does not overrule agreements outlined in the Clinical Investigation Protocols, Steering Committee Charters, or Publications charters, as signed. It is noteworthy that ECRI is represented in all instances by its Director or an assigned delegate.

The policy is defined by the following 8 sections:

1. Submission and approval process for statistical output
   1. ECRI receives the request (template available at ECRI)
   2. If the trial life cycle has not ended (see section 8), ECRI consults the corresponding principal investigator (and/or publication committee) for priority, relevance, scientific value, and novelty
   3. If the trial life cycle has ended (see section 8), ECRI decides based on priority, relevance, scientific value, and novelty
   4. ECRI explores the needed resources (e.g. time, effort, budget)
   5. ECRI decides within 30 working days and informs the requesting party about the decision in writing:
      1. Approved, granting start of activities
      2. Postponed, due to competing priorities or resources
      3. Rejected, due to lack of relevance, scientific value or novelty
   6. A request can be re-submitted if conditions of postponement or rejection changed

2. The following individuals/organizations may submit a proposal for statistical analyses to ECRI:
   1. Members of steering committees (active or past)
   2. Local investigators or national lead investigators, with priority for high-enrollers
   3. Grant-givers of the study
   4. ECRI faculty
   5. Other renowned individuals or organization (see section 8)
      
      
3. Central list of planned publications:
   1. Request for a publication is submitted using a template (available at ECRI)
   2. Once a request is approved, it is captured in the study-specific list of approved analyses
      
      
4. Database management and statistics
   1. The statistical partner of ECRI is Cardialysis. Only databases at Cardialysis are authorized for analyses through this policy
   2. Databases (i.e. patient level data) from ECRI trials may not be shared to other organizations by any party (i.e. database hosting partner, statistical reporting partner). Only ECRI will oversee, approve, and execute data sharing activities
   3. Documentations of statistical programs will be kept at Cardialysis, also when other statistical groups are involved
   4. For each sub-analysis, final documentation of statistical programs, results generated, are kept at the trial master file of the clinical trial at Cardialysis

5. Database ownership and access
   1. The sole owner of the study databases is ECRI, unless specified otherwise in formal agreements (e.g. in case of co-sponsorships). This ownership relates to deciding where to host the database, deciding where to run statistical analyses, mechanisms to ensure security and integrity of the database, and who to provide access
   2. Access means that results obtained from trial databases are shared per request of an individual or organization, for publication purposes or for other (e.g. clinical study reports, safety reporting, regulatory request)
   3. Steering committees of ECRI trials have full access to the trial database, meaning that all results can be provided, however, this section explicitly excludes the transfer of the study database, sub-parts, listings, or patient-level data
   4. As outlined in section 3, copies of the database can be offered to trusted professional partners (e.g. academic institutions) based on a signed agreement and following good clinical practice for trial reporting. Having an authorized copy of the database for publication purposes, still requires all steps mentioned for request of topics, approval of topics, and documentation of statistical procedures. Use of unauthorized copies of study databases represent a violation of good clinical practice and this policy, and may lead to legal actions
      
      
6. Articles submitted for publication
   
   1. All publications derived from ECRI databases require explicit approval, including timely review (i.e. standard time of 30 days, expedited review of 15 days), by the ECRI director (incl. specialty consultants and statistical review if necessary). ECRI reserves the right to include one to three co-authors. ICJME standards must be fulfilled
   2. Not following Article 6.1 represents a violation of this policy, which may disrupt collaboration
      
      
7. Project Management during the study life cycle
   
   1. Every ECRI trial has an appointed Project Manager at Cardialysis, who oversees the execution of the study within timelines and budget
   2. The Project Manager may act as an intermediary between the stakeholders and ECRI during the execution of the study
   3. Study specific publications (agreed per contract) do not need to be re-submitted to ECRI (i.e. already approved), however, all subsequent steps for review and final approval are followed
   4. Once a study is closed (per study-specific agreements) or the study life cycle has ended (whichever comes first), the main contact for ECRI trials is the ECRI director
      
      
8. Data sharing policy
   1. Data sharing is at discretion of the sponsor (ECRI) and it requires collaborative actions with the study-specific steering committee, during the study life cycle
   2. The study life cycle is defined from the initiation up until 3 years after the final pre-defined publication of the study. Pre-defined publications include formal analysis time points, including the primary endpoint and any other subsequent planned time points
   3. Three years after completion of the study life cycle, the steering committees changes status from active to past, and future decisions are to be performed independently by the sponsor
   4. Three years after completion of the study life cycle, ECRI formally adopts a policy for data sharing that is summarized below:
      1. Renowned academics or institutions may request data analyses for publication purposes per Article 1 of this policy (sharing of TLFs)
      2. Renowned academics or institutions may request data pooling activities, by providing databases to ECRI in pre-specific formats
      3. Grant-givers, donors, or manufacturers, may request data analyses in compliance with applicable regulations and existing ECRI agreements
      4. ECRI faculty and research fellows have full access to studies with completed life cycles

Updated: 22 April 2025