The topics in this section help study administrators set up, integrate, and manage study data. This page also outlines the study data model
, helpful for planning study structure.
- Create a Study - Create a new study.
- Create and Populate Datasets - Define datasets and import data.
- Visits and Dates - Configure how the study schedule is defined and tracked.
- Study Management - Manage study participants, datasets, visits, cohorts, quality control, and security.
- Import, Export, and Reload a Study - Transfer studies between servers, duplicate them within a server, synchronize them with a master database, and more.
- Publish a Study - Publish a selected subset of data from a study.
- Publish a Study: Protected Health Information / PHI - Handle protected health information when publishing a study.
- Publish a Study: Refresh - Refresh data in a published study from the original source study.
- Ancillary Studies - Select a subset of data from study to explore new hypotheses and/or set up follow up studies.
Study Data Model
The core entities of a Study (its "keys") are Participants
(identified by "Participant IDs") and Time
, either Visits (identified by "Visit IDs" or "SequenceNums") or Dates.
Participants appear at planned locations (Sites) at expected points in time (Visits) for data collection. At such Visits, scientific personnel collect Datasets (including Clinical and Assay Datasets) and Specimens. These are all uploaded or copied to the Study.
Participant/Visit pairs are used to uniquely identify Datasets and Specimens. Optionally, Sites can also be used as "keys." In this case, Participant/Visit/Site triplets uniquely identify Specimens.
A Study also tracks and manages Specimen Requests from Labs, plus the initial delivery of Specimens from Sites to the Specimen Repository.