Data clarification form
Encyclopedia
A Data Clarification Form (DCF) or Data Query Form (DQF) is a questionnaire specifically used in clinical research
. The DCF is the primary data clarification tool from the trial sponsor or Contract Research Organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data validation process in a clinical trial.
In clinical trials, the data validation step and asking the investigator for clarification of discrepancies (data cleaning) is an important step towards creating a clean dataset suitable for statistical
analysis of the clinical trial outcome.
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
. The DCF is the primary data clarification tool from the trial sponsor or Contract Research Organization (CRO) towards the investigator to clarify discrepancies and ask the investigator for clarification. The DCF is part of the data validation process in a clinical trial.
In clinical trials, the data validation step and asking the investigator for clarification of discrepancies (data cleaning) is an important step towards creating a clean dataset suitable for statistical
Statistics
Statistics is the study of the collection, organization, analysis, and interpretation of data. It deals with all aspects of this, including the planning of data collection in terms of the design of surveys and experiments....
analysis of the clinical trial outcome.
See also
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Clinical trial protocolClinical trial protocolA clinical trial protocol is a document that describes the objective, design, methodology, statistical considerations, and organization of a clinical trial...
- Case Report FormCase Report FormA Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site...
- Patient-reported outcomePatient-reported outcomeA patient-reported outcome or PRO is a questionnaire used in a clinical trial or a clinical setting, where the responses are collected directly from the patient.-Overview:...
- Clinical data acquisitionClinical data acquisitionAcquisition or collection of clinical trial data can be achieved through various methods that may include, but are not limited to, any of the following: paper or electronic medical records, paper forms completed at a site, interactive voice response systems, local electronic data capture systems,...
- Electronic Data CaptureElectronic Data CaptureAn Electronic Data Capture system is a computerized system designedfor the collection of clinical data in electronic format for use mainly in human clinical trials.Typically, EDC systems provide:* a graphical user interface component for data entry...
- Clinical research associateClinical research associateA clinical research associate is a profession defined by Good clinical practice guidelines .The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract...
(CRA) - Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...