Data Management

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

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DF/HCC Policies and Operations

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.
Research teams with access to OnCore can obtain MFRs by navigating to Reports > Data Management. More information can be found here: How to View Missing Forms Reports.
The MFRs for many new trials are also available for study teams to view directly within InForm. CTRIO will notify the study team by email when this feature is enabled.
To access the MFR via InForm:
1. Log into InForm
2. Click on “Reports”
3. Click the folder “MFR and DSMC”
4. Choose either the MFR (site-specific) or DSMC summary.
It may not be immediately obvious that each report has multiple pages. To see all details, click on the “page down” option. You can also view the full report by selecting the “View in PDF” function in the upper right corner.
Generally, baseline forms are due within 30 days of registration and all other forms are due ~2 weeks after the expected end of each timepoint.
Survival information needs to be updated per the protocol schedule. Depending on the protocol, the MFR will show either survival or follow up forms as missing when the survival information has not been updated, even if the form appears complete in InForm.
No. The MFR verifies whether expected data has been entered. Query status is not considered.
The MFR predicts the number of timepoints, forms, and assessments that should have occurred (per the protocol schedule) based on how long each subject has been on study and the subject status in OnCore.
If a visit or form hasn't been created or triggered in InForm, the MFR will anticipate that the visit/forms should have been completed and count them as missing.
Note: InForm uses dynamic forms and form sections to facilitate data entry. Dynamic forms and sections appear based on how certain trigger questions have been answered in the system. If trigger questions are incomplete, dynamic forms may not appear but will still be expected by the MFR.
Please enter a “Not Done” or “Not Applicable” form level comment. Use the comment bubble at the top right of the form to do so, rather than the field level comment bubbles next to each field.
If there are multiple assessments in a given cycle/visit, a form should be created for each assessment with a separate form level comment identifying which day/timepoint was not done.
Usually, the MFR will identify the form level comment and recognize that no data is missing. However, for some trials, manual editing of the MFR may be required. In this case, please email ODQDataManagement@dfci.harvard.edu.
Unfortunately, there is no way to delete a visit once it's been created.
If the subject is returning for another visit in the future, you can come back and enter the information after the next visit occurs.
If the subject will not be returning for another visits, please enter a form level comment on the DOV form indicating the visit was created in error, and then add a form level comment on each form within the visit to mark them as complete.
Please contact the Overall PI and biostatistician for the protocol and confirm that no baseline/screening data needs to be captured for the subject. Forward the written confirmation from the Overall PI and biostatistician to ODQ and we can request to have the subject removed from the database and the MFR.
The MFRs are designed to predict the number of data forms that would normally be required for each participant based on the information available (e.g., subject status dates in OnCore). However, every computer program has limitations, and there are infrequent situations that are difficult for the program to interpret correctly. We ask study teams to review the MFRs and notify us as soon as possible if there’s an error in the program.
External sites should contact the DF/HCC Coordinating Center (lead study team) with questions about missing data. DF/HCC study teams may contact ODQDataManagement@dfci.harvard.edu for assistance with any MFR questions or discrepancies.

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

Please provide additional advance notice for large amounts of data.

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

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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.