Clinical data submitted to the database either meet (1) clinical trials standards or (2) cohort standards.
Clinical Trial Standards
Compliance to Good Clinical Practice (GCP) standards assures that quality control has been applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
- Data have been monitored to ensure that reported trial data are accurate, complete and verifiable from source documents.
- Monitoring will also ensure that the rights and well-being of human subjects are protected (i.e. ensuring informed consent was obtained appropriately)
- Edit checks have been run and resolved
Clinical Cohort Standards
- Data comply with the principles of the Declaration of Helsinki. Investigators contributing data to this database will be asked to sign a statement to verify that informed consent was obtained in the original study data were collected from.
- Data collected should be collected under a protocol or proposal detailing the study design so that data is collected consistently. Investigators will be asked to sign a statement confirming this.
Sequence data included in the database meet the following criteria:
- All data submitted must follow a written genotyping protocol or procedure to ensure data consistency.
- Laboratories submitting data shall be accredited from a local regulated body (i.e. CLIA/CAP), to ensure the laboratory is complying to Good Laboratory Practice (GLP) standards.
Minimal Length and standard of Sequence:
Protease: A bi-directional sequence of the protease gene from codons 10 to 99.
RT : A bi-directional sequence of the reverse transcriptase gene from codons 41 to 235.