Clinical data acquisition
Encyclopedia
Acquisition 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, or central web based systems.
There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial
with the exception of the protocol, which specifies the conduct of that clinical trial
. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial
, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.
The ICH guidelines on Good clinical practice
(GCP) use the term ‘Case report form
’ or ‘CRF’ to refer to these systems 1 . No matter what CRF is utilized, the quality and integrity of the data is of primary importance. The following recommendations are meant to assist in the design, development and quality assurance of the CRF such that the data collected will meet the highest standards.
For an extensive discussion regarding creation of CRFs and examples of actual data collection forms, see Data Collection Forms for Clinical Trials by Spilker 2 . The following is meant to highlight some of the most important points to consider during the design process.
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...
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
Electronic Data Capture
An 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...
systems, or central web based systems.
There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial
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...
with the exception of the protocol, which specifies the conduct of that clinical trial
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 quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the clinical trial
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...
, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention.
The ICH guidelines on Good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
(GCP) use the term ‘Case report form
Case Report Form
A 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...
’ or ‘CRF’ to refer to these systems 1 . No matter what CRF is utilized, the quality and integrity of the data is of primary importance. The following recommendations are meant to assist in the design, development and quality assurance of the CRF such that the data collected will meet the highest standards.
For an extensive discussion regarding creation of CRFs and examples of actual data collection forms, see Data Collection Forms for Clinical Trials by Spilker 2 . The following is meant to highlight some of the most important points to consider during the design process.
Minimum standards
- Design the CRF to collect the data specified by the protocol.
- Document the process for CRF design, development, approval and version control.
- Make the CRF available at the clinical site prior to enrollment of a subject.
- Document training of clinical site personnel on the protocol, CRF completion instructions and data submittal procedures prior to enrollment of a subject.
Best practices
- Design the CRF along with protocol to assure collection of only the se data the protocol specifies.
- Keep questions, prompts and instructions clear and concise.
- Design the CRF to follow the data flow from the perspective of the person completing it, taking into account the flow of study procedures and typical organization of data in a medical record.
- Avoid referential and redundant data points within the CRF whenever possible. If redundant data collection is used to assess data validity, the measurements should be obtained through independent means.
- Design the CRF with the primary safety and efficacy endpoints in mind as the main goal of data collection.
- Establish and maintain a library of standard forms.
- Make the CRF available for review at the clinical site prior to approval.
- Use NCR (no carbon required) paper or other means to assure exact replicas of paper collection tools.
See also
- Clinical Data Interchange Standards Consortium (CDISC)Clinical Data Interchange Standards ConsortiumClinical Data Interchange Standards Consortium is a non-profit organization, whose mission is "to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health-care". Their main project, the...
- 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 Data Management SystemClinical data management systemA clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS...
(CDMS) - Clinical Document ArchitectureClinical Document ArchitectureThe HL7 Clinical Document Architecture is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange.CDA is part of the HL7 version 3 standard...
(CDA) - Health Insurance Portability and Accountability ActHealth Insurance Portability and Accountability ActThe Health Insurance Portability and Accountability Act of 1996 was enacted by the U.S. Congress and signed by President Bill Clinton in 1996. It was originally sponsored by Sen. Edward Kennedy and Sen. Nancy Kassebaum . Title I of HIPAA protects health insurance coverage for workers and their...
(HIPAA) - Directive 95/46/EC on the protection of personal dataDirective 95/46/EC on the protection of personal dataThe Data Protection Directive is a European Union directive which regulates the processing of personal data within the European Union...
- Health Level 7Health Level 7Health Level Seven , is an all-volunteer, non-profit organization involved in development of international healthcare informatics interoperability standards...
- SNOMEDSystematized Nomenclature of MedicineThe Systematized Nomenclature of Medicine is a multiaxial, hierarchical classification system . As in any such system, a disease may be located in a body organ which results in a code in a topography axis and may lead to morphological alterations represented by a morphology code.-Purpose:SNOMED...
- 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:...
- Data managementData managementData management comprises all the disciplines related to managing data as a valuable resource.- Overview :The official definition provided by DAMA International, the professional organization for those in the data management profession, is: "Data Resource Management is the development and execution...
- Title 21 CFR Part 11Title 21 CFR Part 11Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration guidelines on electronic records and electronic signatures in the United States...
- SmartPen - technological system for digitally encoding and transmitting Case Report Forms