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

Table of Contents

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.

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  1. Participants in OC are registered to the linked Collection Protocol in OS.

  2. Data for all the OC CRFs are duplicated in OS Forms.

  3. 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

  1. OC plugin installed in OS.

  2. Server configuration is done. Reference: https://openspecimen.atlassian.net/wiki/x/EQBFVQ

Integration points

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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

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

Import JSON feature

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  1. 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.

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

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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.

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