Clinical data management system
Encyclopedia
A 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. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
The data in CDMS are then transferred for the data validation. Also, in these systems during validation the data clarification from sites are done through paper forms, which are printed with the problem description and sent to the investigator site and the site responds by answering on forms and mailing them back.
Such systems eliminate paper usage in clinical trial validation of data.
Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered around two areas — adverse event
terms and medication
names. With the variance on the number of references that can be made for adverse event
terms or medication
names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the adverse event
terms or medication
names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare them to the dictionaries. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term. As an example, ASA (acetylsalicylic acid) could be mapped to aspirin
, a common notation. Popular adverse event
dictionaries are MedDRA
and WHOART
and popular Medication dictionaries are COSTART
and WHO Drug Dictionary
.
At the end of the clinical trial the data set in the CDMS is extracted and provided to statisticians for further analysis. The analysed data are compiled into clinical study report and sent to the regulatory authorities for approval.
Most of the drug manufacturing companies are using Web-based systems for capturing, managing and reporting clinical data. This not only helps them in faster and more efficient data capture, but also speeds up the process of drug development. Medidata RAVE is an example of a Web-based data capture system. In such systems studies can be set up for each drug trial. In-built edit checks help in removing erroneous data. The system can also be connected to other external systems. For example, RAVE can be connected to an IVRS facility to capture data through direct telephonic interviews of patients.
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...
are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
Classification
The CDMS can be broadly divided into paper-based and electronic data capturing systems.Paper-based systems
Case report forms are manually filled at site and mailed to the company for which trial is being performed. The data on forms is transferred to the CDMS tool through data entry.The most popular method being double data entry where two different data entry operators enter the data in the system independently and both the entries are compared by the system. In case the entry of a value conflicts, system alerts and a verification can be done manually. Another method is Single Data Entry.The data in CDMS are then transferred for the data validation. Also, in these systems during validation the data clarification from sites are done through paper forms, which are printed with the problem description and sent to the investigator site and the site responds by answering on forms and mailing them back.
Electronic data capturing systems
In such CDMS the investigators directly uploads the data on CDMS and the data can then be viewed by the data validation staff. Once the data are uploaded by site, data validation team can send the electronic alerts to sites if there are any problems.Such systems eliminate paper usage in clinical trial validation of data.
Clinical data management
Once the data have been screened for typographical errors, the data can be validated to check for logical errors. An example is a check of the subject's age to ensure that they are within the inclusion criteria for the study. These errors are raised for review to determine if there are errors in the data or if clarifications from the investigator are required.Another function that the CDMS can perform is the coding of data. Currently, the coding is generally centered around two areas — adverse event
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
terms and medication
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
names. With the variance on the number of references that can be made for adverse event
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
terms or medication
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the adverse event
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
terms or medication
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
names can be linked to one of these dictionaries. The system can check the data in the CDMS and compare them to the dictionaries. Items that do not match can be flagged for further checking. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct term. As an example, ASA (acetylsalicylic acid) could be mapped to aspirin
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...
, a common notation. Popular adverse event
Adverse event
An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...
dictionaries are MedDRA
MedDRA
MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology used by regulatory authorities and the regulated biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing activities, and for data...
and WHOART
WHOART
The WHO Adverse Reactions Terminology is a dictionary meant to serve as a basis for rational coding of adverse reaction terms. The system is maintained by the Uppsala Monitoring Centre , the World Health Organization Collaborating Centre for International Drug Monitoring.-Structure:* 32...
and popular Medication dictionaries are COSTART
COSTART
The Coding Symbols for a Thesaurus of Adverse Reaction Terms was developed by the United States Food and Drug Administration for the coding, filing and retrieving of post-marketing adverse reaction reports. COSTART provides a method to deal with the variation in vocabulary used by those who...
and WHO Drug Dictionary
WHO Drug Dictionary
The WHO Drug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre....
.
At the end of the clinical trial the data set in the CDMS is extracted and provided to statisticians for further analysis. The analysed data are compiled into clinical study report and sent to the regulatory authorities for approval.
Most of the drug manufacturing companies are using Web-based systems for capturing, managing and reporting clinical data. This not only helps them in faster and more efficient data capture, but also speeds up the process of drug development. Medidata RAVE is an example of a Web-based data capture system. In such systems studies can be set up for each drug trial. In-built edit checks help in removing erroneous data. The system can also be connected to other external systems. For example, RAVE can be connected to an IVRS facility to capture data through direct telephonic interviews of patients.
See also
- Clinical data managementClinical data managementClinical data management encompasses the entry, verification, validation and quality control of data gathered during the conduct of a clinical trial.-Role of the Clinical Data Manager in a Clinical Trial:...
- Clinical trial management systemClinical Trial Management SystemA Clinical Trial Management System, also known as CTMS, is a customizable software system used by the biotechnology and pharmaceutical industries to manage the large amounts of data involved with the operation of a clinical trial...
- 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...
- 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...
- Electronic Common Technical Document (eCTD)
- 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...