Difference between revisions of "Study attributes"
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| + | 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: | ||
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| − | + | ===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.<br/> | |
| − | + | The options in the NDR system are taken from the largest registry, ClinicalTrials.gov, (from its overall_status field). They are listed below: | |
| − | The options in the NDR system are taken from the largest | ||
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|- style="vertical-align:top;" | |- style="vertical-align:top;" | ||
| 0 || Unknown status|| style="padding-bottom:10px;" | Status information not provided. || style="text-align:center;" | ClinicalTrials.gov | | 0 || Unknown status|| style="padding-bottom:10px;" | Status information not provided. || style="text-align:center;" | ClinicalTrials.gov | ||
| + | |} | ||
| + | |||
| + | ===Gender Eligibility Types=== | ||
| + | Studies may be open only to female participants, or only male, or both. This categorisation reflects that. | ||
| + | {| class="wikitable" style="width: 95%;" | ||
| + | |- | ||
| + | ! style="width: 3%; text-align:left;" | id !! style="width: 20%; text-align:left;" | name !! description !! style="width: 15%;" | source | ||
| + | |||
| + | |- style="vertical-align:top;" | ||
| + | | 900 || All || || style="text-align:center;" | ClinicalTrials.gov | ||
| + | |||
| + | |- style="vertical-align:top;" | ||
| + | | 905 || Female || || style="text-align:center;" | ClinicalTrials.gov | ||
| + | |||
| + | |- style="vertical-align:top;" | ||
| + | | 910 || Male || || style="text-align:center;" | ClinicalTrials.gov | ||
| + | |||
| + | |- style="vertical-align:top;" | ||
| + | | 915 || Not provided || || style="text-align:center;" | ClinicalTrials.gov | ||
| + | |||
| + | |- style="vertical-align:top;" | ||
| + | | 0 || Unknown status || || style="text-align:center;" | ClinicalTrials.gov | ||
|} | |} | ||
Revision as of 11:18, 31 March 2020
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 | source |
|---|---|---|---|
| 11 | Interventional | A clinical trial. | ClinicalTrials.gov |
| 12 | Observational | Any form of non-interventional research. | ClinicalTrials.gov |
| 13 | Observational Patient Registry | Collecting data for a designated registry. | ClinicalTrials.gov |
| 14 | Expanded access | Off label usage of a new product for individuals. | ClinicalTrials.gov |
| 15 | Funded programme | With a single or linked series of grants. | ClinicalTrials.gov |
| 0 | Not yet known | Dummy value supplied by default on entity creation. | 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 NDR system are taken from the largest registry, ClinicalTrials.gov, (from its overall_status field). They are listed below:
| id | name | description | source |
|---|---|---|---|
| 11 | Withdrawn | Study halted prematurely, prior to enrolment of first participant. | ClinicalTrials.gov |
| 12 | Available | Recruitment status available on request but no details provided. | ClinicalTrials.gov |
| 13 | Withheld | Recruitment status not provided. | ClinicalTrials.gov |
| 14 | Recruiting | Participants are currently being recruited, whether or not any participants have yet been enrolled. | 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. | ClinicalTrials.gov |
| 16 | Not yet recruiting | Participants are not yet being recruited. | ClinicalTrials.gov |
| 17 | No longer available | Recruitment status no longer available. | ClinicalTrials.gov |
| 18 | Suspended | Study halted prematurely but potentially will resume. | ClinicalTrials.gov |
| 19 | Enrolling by invitation | Participants are being (or will be) selected from a predetermined population. | 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). | 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). | ClinicalTrials.gov |
| 22 | Terminated | Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention. | ClinicalTrials.gov |
| 0 | Unknown status | Status information not provided. | 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 | source |
|---|---|---|---|
| 900 | All | ClinicalTrials.gov | |
| 905 | Female | ClinicalTrials.gov | |
| 910 | Male | ClinicalTrials.gov | |
| 915 | Not provided | ClinicalTrials.gov | |
| 0 | Unknown status | ClinicalTrials.gov |
