The following represents a suggested workflow/steps for closing out your study (i.e. getting to lock) and archiving it.
- The Investigator user role at the site level has the ability to sign records. The study level user role called “Data Specialist,” can also sign records (if you choose to use it). (more about signing)
- Events must have a status of completed before they can be signed.
- Users who can can sign may do so at the event or casebook level:
- Casebook signing. The user can sign a casebook if all scheduled events for that participant have a status of “completed”, “stopped”, or “skipped”.
- Event signing. If all the required forms for a particular participant’s event have a status of complete and no non-required forms in the event are still in-progress, then the user can sign the event by going to the edit screen for that event and choosing Sign. Note: The user will need to mark the event “complete” first on the edit screen in some cases when the system does not do it automatically.
- Tip: Use OpenClinica Insight reports and to show what data has been signed / not signed and pulses to automatically send this information to investigators throughout the course of the study.
Freeze the study. Freezing is a status that prevents data entry or any data changes, but allows queries to continue. Data managers can freeze individual sites or the entire study by editing the site or study settings, respectively. Data may be unfrozen in this same manner.
Lock lock the study. You can lock at the site level, and the study level. You can also lock particular study events for subjects. Once an event is scheduled, a data manager user can lock it.
- The Participant Matrix will provide a clear indication of which data has, or has not, been locked. This can be supplemented with more detailed Insight reports.
- The system will not require data to be signed before it can be locked, and if this is important to your study you will need to check to make sure the data are signed before locking.
- It is simple to unlock an event, site, or study in the same way you lock it (by editing the settings for that object).
Archive Data. Once the study is locked, we recommend archiving your data by extracting it and printing casebooks. Note: OpenClinica will retain your data for as long as you have a subscription, even if your study is in an archived state. So, this step may be optional, or could be performed at a later time.
- Extract your study data in the CDISC ODM XML Full with OpenClinica Extensions format. This extract format includes all your study metadata as well as query related data and audit log data.
- Print casebooks from the Participant Details page. You can print archival casebooks, including queries and audit trail information, giving you a complete record of the participant in the study:
You can print PDF casebooks one participant at a time, or print them all patients in the study (or at a site) by using the JSON or XML format. Simply click the “Get Link” button to see a modifiable URL. For example, the following URL would show the casebook for one participant: https://acme.openclinica.io/OpenClinica/rest/clinicaldata/xml/view/S_DF/SS_DF001/*/*?includeDNs=y&includeAudits=y&includeMetadata=n&showArchived=y
Replacing the SS_DF001 with an asterix (*) would give me casebooks for all the subjects at this site in a single file.
Change the study status to ‘Design’. This will remove the study from counting against your subscription limit. You may reactivate the study at any time by updating the status.
If you are using OpenClinica Insight, please contact OpenClinica support (firstname.lastname@example.org) when your study has been completed and you no longer require the data in Insight so it can be disabled.
Remove users from the study so that they don’t get confused by these studies in Study Runner. (more about user access)