Study attributes

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Last updated: 19/04/2022

The study attributes below are all designed to be used in categorised form.

Study Types

This provides a very broad overall classification of clinical studies according to their type. The classification in the MDR system is taken from ClinicalTrials.gov:

id name description use_in_data_entry source
11 Interventional A clinical trial. true ClinicalTrials.gov
12 Observational Any form of non-interventional research. true ClinicalTrials.gov
13 Observational patient registry Collecting data for a designated registry. true ClinicalTrials.gov
14 Expanded access Off label usage of a new product for individuals. true ClinicalTrials.gov
15 Funded programme With a single or linked series of grants. false ClinicalTrials.gov
16 Other Source data category does not correspond to any listed above, or is explicitly ‘Other’. true ISRCTN
0 Not yet known Dummy value supplied by default on entity creation. false ClinicalTrials.gov

Study Statuses

This provides a categorisation of a study's current status, to give an idea of where the study is within the normal life cycle. This data is often available from trial registry entries. The options in the MDR system are taken from the largest registry, ClinicalTrials.gov, (from its overall_status field). They are listed below:

id name description use_in_data_entry source
11 Withdrawn Study halted prematurely, prior to enrolment of first participant. false ClinicalTrials.gov
12 Available Recruitment status available on request but no details provided. false ClinicalTrials.gov
13 Withheld Recruitment status not provided. false ClinicalTrials.gov
14 Recruiting Participants are currently being recruited, whether or not any participants have yet been enrolled. true ClinicalTrials.gov
15 Active, not recruiting Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled. true ClinicalTrials.gov
16 Not yet recruiting Participants are not yet being recruited. true ClinicalTrials.gov
17 No longer available Recruitment status no longer available. false ClinicalTrials.gov
18 Suspended Study halted prematurely but potentially will resume. true ClinicalTrials.gov
19 Enrolling by invitation Participants are being (or will be) selected from a predetermined population. false ClinicalTrials.gov
20 Approved for marketing The study has concluded and the medical agent that was the focus of the study has been approved for marketing (in the US). false ClinicalTrials.gov
21 Completed The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant’s last visit has occurred). true ClinicalTrials.gov
22 Terminated Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. true ClinicalTrials.gov
24 Other Status given as "other" in source data. true WHO
25 Ongoing Trial is ongoing but recruitment status is unclear. false EU CTR
0 Unknown status Status information not provided. false ClinicalTrials.gov

Gender Eligibility Types

Studies may be open only to female participants, or only male, or both. This categorisation reflects that.

id name description use_in_data_entry source
900 All true ClinicalTrials.gov
905 Female true ClinicalTrials.gov
910 Male true ClinicalTrials.gov
915 Not provided false ClinicalTrials.gov
0 Unknown status false ClinicalTrials.gov