IMACS Registry Executive Committee
An ISHLT appointed Mechanical Circulatory Support (MCS) committee has been established to evaluate the registry on an ongoing basis as to procedures, findings, and adverse events to assure participant safety, confidentiality of records, and registry integrity. The MCS committee will advise the ISHLT Board of Directors and the DCAC when and if changes should be made.
The IMACSŪ Executive Committee
will monitor regularly the data from the registry, review and assess the performance of its operations, and make recommendations, as appropriate, to ISHLT and the DCAC with respect to:
REFERENCESISHLT Mechanically Assisted Circulatory Support Registry Protocol.
- The performance of individual hospitals (including possible recommendation on actions to be taken regarding any hospitals that performs unsatisfactorily).
- Issues related to participant safety and informed consent including notification of and referral for abnormal findings.
- Adequacy of study progress in terms of recruitment, quality control, data analysis, and publications.
- Possible modifications in the study protocol.
- Overall scientific direction of the registry.
(2012). Birmingham, AL