Acquisition or collection of

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

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 An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to stre ...

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

with the exception of the protocol, which specifies the conduct of that

. 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

, 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 (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...

(GCP) use the term ‘

case report form A case report form (or CRF) 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 patient. All data on ...

’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.

Directive 95/46/EC on the protection of personal data The Data Protection Directive, officially Directive 95/46/EC, enacted in October 1995, is a European Union directive which regulates the processing of personal data within the European Union (EU) and the free movement of such data. The Data Pr ...

Electronic data capture An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. EDC replaces the traditional paper-based data collection methodology to stre ...

Health Insurance Portability and Accountability Act The Health Insurance Portability and Accountability Act of 1996 (HIPAA or the Kennedy– Kassebaum Act) is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1 ...

(HIPAA) *

Health Level 7 Health Level Seven or HL7 refers to a set of international standards for transfer of clinical and administrative data between software applications used by various healthcare providers. These standards focus on the application layer, which is "la ...

Patient-reported outcome A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO m ...

* SmartPen – technological system for digitally encoding and transmitting Case Report Forms *

SNOMED The Systematized Nomenclature of Medicine (SNOMED) is a systematic, computer-processable collection of medical terms, in human and veterinary medicine, to provide codes, terms, synonyms and definitions which cover anatomy, diseases, findings, pro ...

Title 21 CFR Part 11 Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly cal ...

References

* Debbie Kennedy, ''CRF Designer'', Canary Publications, * Rebecca Daniels Kush (2003), ''eClinical Trials: Planning and Implementation'', CenterWatch / Thomson Healthcare, * Spilker B.L. Schoenfelder J. (1991), Data Collection Forms in Clinical Trials Raven Press, New York.

External links

FDA Website: Clinical Data Management Regulations

Association For Clinical Data Management

Society For Clinical Data Management
{{DEFAULTSORT:Clinical Data Acquisition Clinical data management Clinical research

See also

References

External links