Any qualified investigator from the Departments of Cardiology or Cardiothoracic Surgery may request our assistance. Below, find information about requesting data from our ACC and STS databases.
- Any qualified investigator from the Departments of Cardiology or Cardiothoracic Surgery may submit a request for the CTU to provide assistance. Note: The CTU is currently unavailable to provide support for basic science research.
- The Clinical Trials Unit’s Medical Director will review and approve all requests.
- The proposed research questions should be logical, comprehensive and clearly stated.
- Approved requests will be executed in the order received - sufficient time should be allowed for project completion.
- The anticipated timeframe from submission of this request to notification of approval (or denial) is approximately 5 business days.
- For denied projects, feedback will be provided to the requesting investigator. Projects may be resubmitted for review.
- If statistical support is requested, a meeting with the biostatistician at least 1 month prior to submission deadline is required. A minimum of 2 weeks for statistical analysis is required.
- It is highly recommended that prior to submitting the Data Request the PI meet with the CTU statistician to define the study research questions, outcomes, predicators, and hypotheses.
- Final abstracts must be submitted to the CTU at least 7 days prior to submission deadline for review and comment by subject matter experts.
- Manuscript or materials proposed for publication must be submitted to the CTU for review and comment at least 14 days prior to the corresponding deadline for review and comment by subject matter experts.
- It is the responsibility of the PI/lead author to obtain approval from ALL Co-authors prior to submission.
- The Data Request Application should be submitted at least 3 months prior to a journal submission
- Failure to follow any of the above may result in inability to publish/present findings and/or to request data/specimens for future projects.
A description of the project must be included with the Service Request Form. The description should include at a minimum: Background, Objectives, Methods/ Analysis, and References sections. In addition, the following points should be addressed:
- The exact nature of the dataset to be developed and used in the analysis
- Date range for cases to be included in the request (e.g. 4/2006- 5/2006)
- Specific database variables to be used (highlight elements on example data collection forms or provide a list of specific variable names). Only elements highlighted or listed will be extracted from the database.
- A table or other detailed illustration of how the data will be presented.
- Specific research questions and specific definitions of major predictors and outcomes
To request data or other services, please submit an online Service Request Form.
All requests are reviewed by the CTU to determine scientific merit, clinical significance, statistical validity and feasibility of completing the study in a timely manner. For approved requests, specimens will be distributed only after receiving a copy of the investigator's IRB approval letter (if applicable) and a signed Research Agreement.