5 Using Data Clarification Forms
To open the Maintain Data Clarification Forms window, from the Conduct menu, select Data Validation, then select Data Clarification Form. You can also navigate to the window directly from the Maintain Discrepancy Database window. See Using the Discrepancy Database.
DCFs enable you to organize discrepancies into groups based on criteria such as Investigator, site, and/or DCM. You specify the criteria and Oracle Clinical creates one DCF for each patient whose records match the criteria. You can create custom header and footer information for the DCF.
A particular discrepancy can appear as ACTIVE on only one DCF. You can manually add and remove discrepancies from DCFs. When a discrepancy's status is updated so that it no longer matches the status criteria for the DCF, the system releases it from the DCF.
Print and Electronic DCFs
After you have created a DCF, you can generate a DCF Report printout listing all its discrepancies and send it to an Investigator for review. Oracle Clinical keeps track of each report generated for each DCF and which discrepancies are described on each page. See Tracking DCF Pages. If you are an Investigator with access to Oracle Clinical, you can view the DCF in the Maintain Data Clarifications Form window, use the link to the Maintain Discrepancy Database window to update discrepancies' status, and use the Update Patient Data link to change incorrectly entered data. Or you can mark your comments on the paper report and send it back for the changes to be entered.
DCF Discrepancy Selection Criteria
The criteria you can use to select discrepancies for inclusion on the DCF are:
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Discrepancy Status. Specify the status of the discrepancies you want to include in the DCF. You can specify those you want to have appear in the report (such as INV REVIEW) and those you want to include in the DCF but do not want to appear in the report (such as PASSIVE REVIEW). You can also choose to include discrepancies with a resolution status; this may be useful when discrepancies have been resolved internally and need only be checked by the Investigator. You must also choose whether or not to include discrepancies with a status of OBSOLETE.
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Any number of the following: Investigator, site, and patient. Oracle Clinical limits your choices to those Investigators, sites, and patients associated with discrepancies that fulfill the status criteria you selected.
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One of the following: Patient, Patient Visit, DCM, or Discrepancy. Oracle Clinical limits your choices to those associated with discrepancies that fulfill the status criteria you selected.
This chapter includes the following topics related to creating and using Data Clarification Forms (DCFs). Information on setting up DCFs is available in the Discrepancy Configuration chapter of the Oracle Clinical Administrator's Guide.
For more information, see: