A clinical data management system or CDMS is a tool used in clinical research to manage the data of a

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

. The clinical trial data gathered at the investigator site in the

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 ...

are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data. Systems for

clinical data management Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availabi ...

can be self-contained or part of the functionality of a CTMS. A CTMS with clinical data management functionality can help with the validation of clinical data as well as helps the site employ for other important activities like building patient registries and assist in

patient recruitment Patient recruitment includes a variety of services—typically performed by a Patient Recruitment Service Provider—to increase enrollment into clinical trials. Presently, the patient recruitment industry is claimed to total $19 billion per year. ...

efforts.

Classification

The CDMS can be broadly divided into paper-based and electronic data capturing systems.

Paper-based systems

Case report In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurr ...

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 Data entry is the process of digitizing data by entering it into a computer system for organization and management purposes. It is a person-based process and is "one of the important basic" tasks needed when no machine-readable version of the inf ...

. The most popular method being

double data entry Two-pass verification, also called double data entry, is a data entry quality control method that was originally employed when data records were entered onto sequential 80-column Hollerith cards with a keypunch. In the first pass through a set of ...

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 CDMSs, the investigators directly upload the data on CDMS, and the data can then be viewed by the data validation staff. Once the data are uploaded by site, the 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 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 date of birth 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 An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can ther ...

terms and

medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field an ...

names. With the variance on the number of references that can be made for

terms or

names, standard dictionaries of these terms can be loaded into the CDMS. The data items containing the

terms or

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 Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat in ...

) could be mapped to

aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat in ...

, a common notation. Popular

dictionaries are

MedDRA A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical ...

and

WHOART The WHO Adverse Reactions Terminology (WHOART) 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 (UMC), the World Health Organization Collaborating Cent ...

and popular Medication dictionaries are

COSTART The Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART) was developed by the United States Food and Drug Administration (FDA) for the coding, filing and retrieving of post-marketing adverse reaction reports. COSTART provides a metho ...

and

WHO Drug Dictionary The WHODrug Dictionary is an international classification of medicines created by the WHO Programme for International Drug Monitoring and managed by the Uppsala Monitoring Centre. It is used by pharmaceutical companies The pharmaceutical ind ...

. 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. 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 (Interactive Voice Response System) facility to capture data through direct telephonic interviews of patients. Although IRT (Interactive Response Technology) systems (IVRS/IWRS) are most commonly associated to the enrollment of a patient in a study thus the system defining the arm of the treatment that the patient will take and the treatment kit numbers allocated to this arm (if applicable). Besides rather expensive commercial solutions, there are more and more open source clinical data management systems available on the market. CDMS implementations are required to comply with 21 CFR Part 11 federal regulations to be used for FDA registered drug trials. Part 11 requirements include audit trails, electronic signatures, and overall system validation.

References

* Stuart Summerhayes, ''CDM Regulations Procedures Manual'', Blackwell Publishing, {{ISBN, 1-4051-0740-5 * Tai BC, Seldrup J., A review of software for data management, design and analysis of clinical trials, Ann Acad Med Singap. 2000 Sep;29(5):576-81. * Greenes RA, Pappalardo AN, Marble CW, Barnett GO., Design and implementation of a clinical data management system, Comput Biomed Res. 1969 Oct;2(5):469-85.

External links