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
- 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: