This document addresses the preparation of data sets and associated documentation from NHLBI-funded clinical studies for deposition into the NHLBI Data Repository.
Data - Information collected and recorded from study participants through: periodic examinations; measurements from biospecimens; quantitative results from procedures such as imaging studies, exercise tests, lung function assessments, etc.; clinical event surveillance and follow-up contacts.
Study documentation – Descriptive information regarding the conduct of the study and collection of Data. Study documentation may include: study protocol, manual of operations or manual of procedures, annotated data collection forms, codebooks or data dictionary, algorithms for calculated or derived data elements, and descriptions of data derived from procedures or biospecimens.
Investigators conducting NHLBI studies subject to the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies may be required as part of the terms and conditions of their awards to prepare and deliver to the NHLBI data sets that satisfy NHLBI requirements. This includes measures to reduce the likelihood that any individual participant can be identified, such as the elimination of personal identifiers. These measures safeguard privacy and honor the informed consent of research participants. Additional requirements include the provision of documentation and key study documents (protocol, data collection forms, manuals of procedures, etc.) that will enable the use of prepared data sets by outside investigators.
Data sets and associated documentation must be provided in electronic form to the Institute. In addition, if a tiered consent was utilized by the study, investigators must provide the Institute with a list of participant identification numbers with data fields indicating:
Investigators conducting ancillary studies based on ongoing (parent) studies that are subject to the NHLBI Data Sharing Policy must also submit ancillary study data to the NHLBI through the parent study coordinating center or data submission process established by the parent study.
Data from scored or procedural assessments (e.g., food item data, psycho-social questionnaires, individual electrocardiographic lead scores, etc.) should include for each participant both raw data elements and summary information where feasible.
Data must be provided in a manner that protects the privacy of study participants. Steps taken to protect participant privacy in preparing a data set must be documented. A summary of all proposed modifications and deletions to be made to a data set should be submitted to and approved by the NHLBI Data Repository representative prior to their implementation.
The following guidelines provide a framework for decision-making regarding preparation of data sets:
Documentation for data sets must be comprehensive and sufficiently clear to enable investigators who are not familiar with a data set to use it. The documentation must include data collection forms, study procedures and protocols, data dictionaries and algorithms for calculated data elements, descriptions of all variable recoding performed, and a list of all study publications to date.
In addition, a summary documentation file is required and must provide a complete overview of the data and a description of their use for investigators who are not familiar with the data set. It must also contain a brief description of the study (including a general orientation to the study, its components, and its examination and follow-up timeline), a listing of all files being provided, and, if applicable, generation program code for SAS-formatted data files or formats.
Selected study documentation will be used to describe the study on the Data Repository website. Examples include Forms, Data Dictionaries, Descriptive Statistics, and the Study Protocol. These documents should be accessible to those with disabilities according to section 508 of the Rehabilitation Act. The DHHS maintains a website devoted to 508 issues with links to resources on creating and checking accessibility at http://www.hhs.gov/web/508/index.html.
A checklist to aid in the preparation of study data and documentation is available on the BioLINCC website. A study details worksheet and informed consent questionnaire must be submitted with the study materials and is also available from the BioLINCC website.
The preferred format for the data is SAS; however, data prepared using any standard statistical software (i.e. SPSS, Stata) or as an ASCII text file, is acceptable. Data submitted in ASCII format must include SAS generation code to convert the file to SAS format. Regardless of data submission format, each data element must be provided with descriptive labels.
Both the comprehensive documentation and the summary documentation must be prepared in a consistent format, either as Word Perfect, MS Word, ASCII, or portable document format (PDF) files and included on the same storage medium as the data set. To ensure access by users with disabilities, all PDF files must be created in Adobe Acrobat version 5.0 or higher. Documentation that is not available in electronic form, such as data collection forms, should be scanned into a graphics file, converted to a PDF file using Adobe Acrobat version 5.0 or higher, and saved on the same medium as the data set. Pedigree data should be provided in a format readable by standard genetic analysis programs such as SAGE and SOLAR, with one individual's data per line beginning with pedigree identifier, individual's ID, father's ID, mother's ID, and individual's sex.
Data and study documentation materials should be sent to the NHLBI prior to the end of funding and within the timelines described in the NHLBI Policy for Data Sharing from Clinical Trials and Epidemiological Studies.
The following links highlight NIH policy and related guidance on sharing of research data developed with NIH funding.
For questions and/or concerns regarding the content of this page, please contact the NHLBI Data Repository representative.
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