Study attributes

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11	Withdrawn	Study halted prematurely, prior to enrolment of first participant.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