Info

Data entry/data upload

 

During this step the data are collected in the OpenClinica database. Data can be entered manually in OpenClinica via the user interface. There is no need for retyping in OpenClinica if the data are already available in an electronic format. In this case the dataset can be uploaded in OpenClinica via the ‘Import Data’ function.

For all types of data entry you need to have a user account in OpenClinica. If you have not built the study/CRFs yourself or if you do not have a user account, see step  Request study on OpenClinica.nl in the preparation phase.;. The user account needs to be requested by a person who has the role of data manager or study director in the OpenClinica study.  For more information about user types and roles within OpenClinica, see: https://docs.openclinica.com/3.1/openclinica-user-guide/overview-user-types-and-roles/actionsbuttons-allowed-user-role

It is recommended to let the OpenClinica study role correspond to the tasks delegated by the Principal Investigator on the Delegated Task List  to ensure that members of the research staff to whom specific study tasks have been delegated (by the principal investigator) are qualified to perform those tasks as demonstrated by evidence of their education, training and experience.

 

Manual data entry in OpenClinica
It is possible to enter data manually in OpenClinica via the user interface. Please see the data entry manual for explanation.

 

Upload of existing data

It is possible to upload existing data in OpenClinica via the OCDI data upload tool. For this, you first need to convert your data file into a tab-delimited text file (encoded in UTF-8), which is the only format that OpenClinica supports.

Please see the data import manual for explanation.

The tool also performs  data checks (verifies if the data definitions in the dataset correspond to the CRF definitions in OpenClinica). If the definitions do not match, you will receive clear messages indicating what needs to be changed (either data in the dataset or CRF definitions in OpenClinica).

The upload of data in OpenClinica always needs to be tested on the OpenClinica Sandbox environment before it can be performed on the production server.

If upload succeeds on the Sandbox server you can perform the actual upload on the production server. The OpenClinica Upload user manual is also available in the knowledge base section of the TraIT Servicedesk.

Note:  Uploading data with the OCDI is a simple process. However preparing the data file requires some programming knowledge and  experience with building studies and CRFs  (type advanced data manager).

Only Study data managers and/or Study directors are allowed to perform a data upload.

Please find below the steps that you need to follow to upload data in the production server:

Step 0: Prepare

  • Request authorization to use the OpenClinica Upload Tool (OCDI) in the OpenClinica Sandbox environment       (via Topdesk Selfservice  -  “OpenClinica Data Upload Request form” ).
  • Convert your data file into a tab-delimited text file according the data file specifications mentioned in the OCDI user manual.

Step 1: Test

  • Run the data importer tool on the tab-delimited text file that you want to upload
    *Select in the OCDI tool as OpenClinica Environment “SANDBOX-TraIT”
  1. Correct mistakes (regarding Subjects, Events & data) by adjusting the data in the source file (in that case you will need to run the tool again)
  2. Complete upload procedure

Step 2: Verify

  • Verify the uploaded data in the OpenClinica sandbox environment

Step 3: Run

  • If the study does not yet exist on the OpenClinica production server
  1. Request  a new study (and possible also a user account) on the production server. You can request this by using the TraIT Servicedesk web form “Request new study”
  2. Build the study exactly as done on the upload test server ( Sandbox)
  • If the study does exist, make sure that the study on the production matches the
    the study on the OpenClinica Sandbox environment.
  • Request authorization to use OpenClinica Upload Tool (OCDI) in the OpenClinica Production      environment       (via Topdesk Selfservice  -  “OpenClinica Data Upload Request form” ).
  • Run the data importer tool on the dataset (tab delimited text file) that you successfully tested in the OpenClinica Sandbox environment
    *Select in the OCDI tool as OpenClinica Environment “PRODUCTION-TraIT”

Step 5: Check

  • Verify the uploaded data in the OpenClinica production environment

Next step: Manage Study

Back to: Execution Phase