The Office of Data Quality is responsible for ensuring timely and accurate data entry for PI-initiated trials within the DF/HCC.
Please contact us at ODQDataManagement@dfci.harvard.edu with any questions.
Missing Forms Reports
Missing forms reports (MFRs) are data expectancy reports that provide research teams with a look at what CRF data may be missing. MFRs are only available for Investigator-Sponsored trials where data is managed by the DF/HCC (e.g., in InForm). MFRs are also provided to the DSMC and DSMB to assist in their oversight activities.
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.
ODQ requires that data be clean (i.e., data entry complete, no outstanding queries) before certain types of requests can be fulfilled.
The number of new queries generated by ODQ in response to a data request depends on the quality and quantity of data requested.
Please direct any questions about the above requirements to ODQDataManagement@dfci.harvard.edu.
Data Request Workflow
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.