Design | Observational vs interventional |
Registry vs RCT | |
Cross-sectional vs longitudinal | |
Inception vs cohort | |
Personalized medicine | |
Participants | Eligibility criteria for cases |
Inclusion of control subjects, especially important for laboratory and imaging biomarkers | |
Sites | Number |
Geographical representation | |
Targeting special populations who
| |
Closed vs open to new sites after commencement | |
Recruitment cap for each site to improve external validity | |
Biosamples contribution
| |
Data management | Effective IT solutions that are robust over time |
NGS-type storage of extremely large datasets | |
Different systems for genomic vs imaging data | |
Data dictionary, to ensure consistency of terminology, especially for clinical terms |
CRN: collaborative research network; RCT: randomized controlled trials; IT: information technology; NGS: next-generation sequencing.