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. In case the request is related to reporting, under no circumstance a submission will be halted based on unfavorable data for a product. ECRI will enforce agreements with grant-givers to review manuscripts in order to protect IP.

This policy applies to all individuals or organizations who rightfully wish to use data collected in an ECRI trial database. This policy does not automatically 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 managing director or an assigned delegate.

The policy is summarized in the following 8 sections:

  1. Submission and approval process for statistical output
    1. ECRI receives the request (template available at ECRI)
    2. ECRI consults the Steering Committee (i.e. priority, relevance, scientific value, novelty)
    3. ECRI explores the needed resources
    4. ECRI decides based on items (b) and (c), as available, within 21 days (or earlier)
    5. ECRI informs the stakeholders about the decision in writing:
      1. Approved, granting start of activities
      2. Postponed, due to competing priorities, 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
    7. ECRI reviews all requests the first week of every month
  1. The following individuals/organizations may submit a proposal for statistical analyses to ECRI:
    1. Members of Steering Committees
    2. Local PIs/ national lead investigators (high-enrollers)
    3. Grant-givers of the study
    4. ECRI faculty
    5. Other organizations (only once data sharing policy is in place for a study)
  2. Central list of planned publications:
    1. As of March 1st 2021, topics need to be submitted to adhere to new format
    2. Request for a publication is submitted using a template (available at ECRI)
    3. Once a request is approved, it is captured in the study-specific list of approved analyses
  3. Database management and statistics
    1. The preferred partner of ECRI for database hosting is Cardialysis, however, ECRI collaborates with other professional partners who per formal agreement host a trial database. For each study, the center(s) formally hosting the trial database are listed at the ECRI website.
    2. The preferred partner of ECRI for statistical reporting is Cardialysis, however, ECRI collaborates with other professional statistical reporting organizations. For each study, the entity formally programming statistical reports on behalf of ECRI are listed at the ECRI website.
    3. Databases (i.e. patient level data) from ECRI trials may not be shared to other organizations by participating third parties (i.e. database hosting partner, statistical reporting partner). Only ECRI will oversee, approve, and execute data sharing activities.
    4. Documentations of statistical programs will be kept at the formally appointed statistical reporting group and at Cardialysis (i.e. when other entities involved).
    5. When analyses are performed by other professional trusted partners, ECRI may require random or selective re-run by Cardialysis, based on review of data.
    6. For each sub-analysis, final documentation of statistical programs, results generated, are kept at the trial master file of the clinical trial at Cardialysis.
  1. Database ownership and access
    1. The owner of a study database is the Sponsor (ECRI). 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 the trial database 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 an ECRI trial have full access to the database of a study, 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. CRO, 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.
  2. Published articles – Refer to Appendix I
    1. Starting March 2021, 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, following accepted publication standards.
    2. For publications before March 2021, the ECRI website will specify ‘publication approved by the Sponsor’ and ‘publication not approved by the Sponsor’, since several publications are now available that have not undergone review and approval by ECRI.
    3. Any use of trial databases need to follow steps signaled in section 4 and 5. Not following such recommendations represent a violation of this publication policy, which may disrupt collaboration (see Section 8).
  3. Role of the Project Manager (Cardialysis)
    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, and shares this Publication Policy at the beginning of the study, and when required
    3. The 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. An ECRI publication can be submitted once approved
    4. Once a study is closed, the main contact for ECRI trials is the ECRI managing director.
  4. Disrupted collaboration
    1. In case of a disrupted collaboration, where the Steering Committee members wish not to follow procedures described in this document, ECRI offers a friendly end of agreement which is summarized as follows:
      1. If a member is no longer recognized as a Steering Committee member by ECRI – which needs to be justified and agreed in writing; the member no longer has rights as to request output from an ECRI database. This scenario is applicable during the study and after ending the study. ECRI makes a final decision.
      2. If a member wishes to ignore the procedures depicted above, but ECRI still recognizes her or him as a Steering Committee member, and “end of co-publishing agreement” is stablished. In summary: a) The full Steering Committee agrees that the member can continue academic exploitation of the study database independently – if there is no agreement, ECRI makes a final decision; b) ECRI agrees that data transfer is possible being the recipient of the study database a recognized researcher with stablished credibility; c) ECRI announces data transfer to the members (i.e. at the ECRI website); d) ECRI maintains ownership and independent publication rights; e) the member has rights to generate scientific output independently; however, in order to avoid duplicate publications, it is sensible that the expert informs ECRI about publishing plans; f) ECRI may validate published results as necessary or per request, and makes results public.
      3. If a member operates ignoring either a Steering Committee member agreement or an ‘end of co-publishing agreement’, actions are in violation of this policy and Good Clinical Practice, and further actions may be taken by the Sponsor to ensure data integrity, patient safety, and observance of the law.