OpenClinica Integration (OC)

This is a paid plugin. Please email contact@krishagni.com for more details.

1 Introduction
2 Supported OC Versions
3 Pre-requisites
4 Integration points
5 OC Study Setup
6 OC Sync
7 Configure Multiple Projects
- 7.1 Add Another feature
- 7.2 Import JSON feature
8 OC Delete Study
9 OC Delete Data
10 Import Dataset XML

Introduction

OpenClinica (OC) is open-source solution for EDC (electronic data collection). OC is used for data management and electronic data capture for clinical research projects.

Integrating OC with OS serves multiple purposes.

Eliminate duplicate data entry - thereby reduced manual data entry, saving time and human errors.
Integrated reporting across clinical and biospecimen data.

Once the two systems are integrated, you can expect the following:

Participants in OC are registered to the linked Collection Protocol in OS.
Data for all the OC CRFs are duplicated in OS Forms.
All the visits and specimens in OC are created in OS under a specific participant.

Supported OC Versions

OC 3.x and OC 4.x.

Pre-requisites

OC plugin installed in OS.
Server configuration is done. Reference: https://openspecimen.atlassian.net/wiki/x/EQBFVQ

Integration points

OpenSpecimen	OpenClinica	Description

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

All configuration should be via UI in OS. No backend or direct SQLs etc.
For every object added from OC to OS (patient, site, visit, CRF, etc.), there should be an entry in an audit log table.
OC or OS database should not be accessed directly. All data access should be via APIs.

OC Study Setup

Refer to https://openspecimen.atlassian.net/wiki/x/F4Ftcg for mapping details.

OC Sync

All the OC CRFs should be available within the OS reporting module for querying specimens.
When a study is linked, its CRFs in OC should be replicated in OS under that study.
If a new version of CRF is updated in OC, it should be configured and synced in OS.

Refer to https://openspecimen.atlassian.net/wiki/x/GAFucg for sync details.

Configure Multiple Projects

It is possible to map multiple OC studies to a single OS study. You can map these studies using ‘Add Another' or ‘Import Study (JSON)’ features.

Add Another feature

Go to the configured OC study → Click on ‘More’ → ‘Add Another’ will allow you to add the next study.

Import JSON feature

Go to the configured OC study → Click on ‘More’ → ‘Import Study (JSON)’ → Import JSON file. This will allow you to add the next study.

2. Choose a JSON file and click on 'Submit.

3. Once the study is imported, you will get a notification on the screen as below.

Important details to verify before importing JSON

A. The study 'Name' should be unique under each protocol.

B. The server available in JSON should be configured in OS.

C. The sites and events available in JSON should be configured in OS.

Refer to a demo json file.

The multiple configured studies look like below.

You can edit the study details using the edit option as shown in the below image.

To see all the configured studies, you can use the 'View Studies' feature as shown below.

OC Delete Study

Refer to https://openspecimen.atlassian.net/wiki/x/vIFtcg for deleting the OC mapping and table details.

OC Delete Data

Refer to https://openspecimen.atlassian.net/wiki/x/PoDAcg for deleting mapping data details.

Import Dataset XML

It is possible to import the dataset XML for the study mapping.

<TBD: Upload sample report>