Data Management

The Office of Data Quality helps to ensure timely and accurate data entry on DF/HCC Investigator-Sponsored clinical trials. 

Missing Forms Reports

Data Requests

To request Case Report Form (CRF) data from an Investigator-sponsored protocol where data is maintained within the DF/HCC, please submit an online Data Request Form.  

*Note:
If you will be using the DF/HCC Biostatistics Core, please make sure to provide the required notification to the biostatistician. See: http://www.dfhcc.harvard.edu/research/core-facilities/biostatistics/

Data Request Requirements

Data requests must be:

  • Submitted at least 2 weeks in advance (Inform)
  • Submitted at least 4 weeks in advance (paper CRFs)
  • Approved by the Overall PI and responsible biostatistician

Research teams should be prepared to resolve queries on the data during the data request process. The number of new queries generated by ODQ in response to a data request depends on the quality and quantity of data requested.

Data Request Workflow

Study Completion

Prior to study completion, ODQ will verify the following:

  • All CRFs data is complete; all queries resolved (when data is managed within the DF/HCC)
  • All subjects are off-study (for trials that register in OnCore)
  • ClinicalTrials.gov record is complete and up to date (for trials registered to ClinicalTrials.gov)

If any of the above apply, OHRS requires confirmation from ODQ before a study can be completed with the IRB. Please initiate an online ODQ Study Completion Request to begin this process.