Introduction

OpenClinica (OC) is world's leading open source solution for EDC (electronic data collection). Both the solutions provides complimentary benefits to research centers. OC is used to collect data for clinical studies and OpenSpecimen (OS) is used for biospecimen collection for the same study.

Goals of the integration

Reduce manual data entry and thereby save data time and human errors
Link data points between OS and OC (E.g. studies, participants, visits)
Use OpenSpecimen's query interface to look for samples based on OC and OS

Integration points

OpenSpecimen	OpenClinica	Description
Collection Protocol	Study	In OpenSpecimen CP UI, it should be possible to configure which OC study does it link with.
Participant	Subject	An OpenClinica subject should get registered as OS participant under the linked collection protocol. The OC "subject ID" should be used as OS "PPID".
Visit	Visit	An OC Visit should get added as Visit in OS under the same participant.
Forms	CRF	Every CRF under the OC study should get replicated as OS "forms". These will be "read only" and to be used only for reporting i.e. query for samples based on biospecimen data and clinical study data.

Important notes

No code changes in OC
All configuration should be via UI. No backend or direct SQLs etc.
Integration should happen in real-time as much possible. CRF sync'ing can be nightly if there are technical challenges.
For every object added from OC to OS (patient, site, visit, crf, etc) there should be an entry in an audit log table (this can be a central table e.g. object_type, OC_ID, OS_ID, created_date, last_updated_date)
OC or OS database should not be accessed directly. All data access should be via APIs.

Error handling:

An error log table should be present to log all errors.
Error should be emailed to the system admin too.
Error should be accompanied with meaningful errors.

Study and Site link

It should be possible to link an OC study to OS collection protocol. This can be done either by displaying a dropdown of OC studies (via an OC API to get all studies) OR just giving a text box to enter the OC study code/title.
Configuration should include OC URL/instance. This will enable different studies to have different OC instances.
Same for Site.

Patient and visit link

This is one way link from OC to OS.
When a patient is registered in OC, it should get automatically registered in OS for the linked study.
The “study ID” field in OC should be duplicated as PPID field in OS.
It should be possible to map fields to OC to either static domain object fields or extension fields of OS
Ditto to Visits.

CRF syncing

All the OC CRFs should be available within OS reporting module for querying for specimens.

Metadata synching

When a study is linked, its CRFs in OC should be replicated in OS under that study.
In OC these will be visit level CRFs.
If a new version of CRF is updated in OC, it should be synced in OS

CRF data syncing

Each time a CRF is CRUD in OC, it should be synced in OS