International Network of VENous Thromboembolism Clinical Research Networks

Study Endorsement

Rationale

Clinical studies, and especially randomized controlled trials (RCT), frequently require international collaboration and participation from multiple clinical centres to meet sample size requirements in a timely manner. Conducting clinical research in multiple countries offers the advantages of faster participant recruitment and study completion, and greater generalizability of results. 

The INVENT Network aspires to be the international driver and accelerator for patient-oriented, investigator-initiated clinical venous thromboembolism (VTE) research and to be the key facilitator for international collaboration among VTE clinical investigators.

​Objective

INVENT’s study review and approval process is intended to identify studies that align with the Network’s aspirations and which the Network will endorse.

 The formal review process provides a mechanism for INVENT Council Members to jointly determine which studies the network will promote and support.

​Eligibility

Applicants: the proposed study must be supported/developed by members of two or more INVENT-member organisations. Applicants must be committed to international collaboration, ethical research practices, and fair recognition of co-investigators’ research contributions.

Study stage: research at any stage of development is eligible for endorsement by the INVENT Network. Investigators may apply for approval of a research idea or preliminary protocol, a study with a fully-developed protocol, or one that is actively recruiting participants.

Research design: academically-driven clinical research studies that are seeking to recruit participants in multiple countries.

Competing studies: ideally, the proposed study is unique and does not replicate or compete with an ongoing study. Applicants are expected to make efforts to identify other studies that are in progress that are seeking to answer the same or a similar research question. Justification for undertaking a similar study must be provided.

​Application Process

An INVENT Council Member sends the INVENT Chair an application package consisting of the following documents:

A completed INVENT Study Approval Application Form

A one-page proposal for the study

​Review and Approval Process

  1. The INVENT Staff and Chair conduct an initial review for completeness and clarity.
  2. The INVENT Chair circulates the application via email to Council for review and comments.
    1. The proposal may be sent back to proponents for refinement/comments/questions prior to approval and endorsement.
    2. Applicants requesting approval of a research idea or preliminary proposal are expected to provide additional study details once the proposal is developed. Studies that have already received approval will not require formal review again.
  3. At the next INVENT Council Meeting (teleconference or in-person), and a minimum of 1-month after the proposal was circulated, a vote will be conducted to establish support for the study and approval for calling it an INVENT study.
  4. All Council members may vote, in person or by proxy, to approve a study, regardless of their involvement or interest in the study. For the voting process, quorum is 30% (in person or by proxy) and a majority vote in one where more than half of the members of Council present and voting vote in the affirmative.

​INVENT Support of Endorsed Studies

  1. A letter of endorsement will be provided (upon request, the letter may be tailored to include in a funding application, etc.)
  2. A study summary will be posted on the INVENT website.
  3. The study will be promoted to members via email and social media tools.
  4. Endorsed studies will have access to INVENT resources; e.g. use of adjudication platform at “academic rate.”
  5. INVENT Council Members will actively promote endorsed studies within their national networks.

Submission instructions: Please open the .PDF file using Adobe - not in your browser. If you are unable to submit the form, please manually save and send your completed application to info@invent-vte.com or simply use the word version available for download.

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