Clinical Data Capture System
A Clinical Data Capture System is a Data Capture System that collects clinical data and moves it onto a database.
- AKA: Clinical Data Acquisition System.
- Context:
- It can range from being a Paper-based Clinical Data Capture System to being a Digital-based Clinical Data Capture System.
- Example(s):
- Counter-Example(s):
- See: Case Report Form, Clinical Trial, Good Clinical Practice, ePRO, eCOA, eClinical.
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_data_acquisition Retrieved:2021-12-12.
- 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’ (CRF) to refer to these systems. No matter what CRF is utilized, the quality and integrity of the data is of primary importance.
- 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.
2000
- (Waterfield, 2000) ⇒ Emma Waterfield. "4. Data Capture" In: Clinical Data Management. Second Edition, 75-87. Edited by R.K. Rondel, S.A. Varley and C.F. Webb.
- QUOTE: Traditionally, data capture has meant manual entry of data by trained specialist data entry operators who input data from a paper case record form (CRF) onto a central database via pre-set data entry screens, using a conventional keyboard. Data entry might occur only once (single entry) or successively (double entry), the latter with input by a second, separate data entry operator. Double entry aims to increase accuracy by highlighting the differences between the two operators' versions of the data. Reconciliation between the two entries may be achieved by either of two - methods. On-line data point to data point verification by the second, more experienced data entry operator calls for a judgement to be made between the two conflicting entries, or flagging of the discrepancy for further invetigation by CDM staff. An alternative is to run a report after double data entry which compares the two entries and indicates the inconsistencies. Subsequent comparison of the non-matching variables must then be accomplished by CDM staff before the data are transferred to the production area of the database. This represents an additional, time-consuming step in the data entry process (...)
The drive to speed up the process by which clinical data are captured onto a centralised database has seen the development of more sophisticated scanning technology. When scanned, each mark on the original CRF page is viewed as a matrix of tiny dots which are stored electronically in the system so that an image can be assessed on a VDU screen rather than printed as a hard paper copy. The improvement over fax technology is that images can be recognised and stored in such a way that the information can later be deciphered. The step by which the optical image is interpreted onto the electronic database is known as automated data acquisition(...)
Remote data entry means data capture at the point at which it is generated. If electronic transfer of the data to the sponsor's system occurs regularly, the data can be accessed and reviewed much more quickly than has been possible using traditional data capture methods. Crucially, the data can be validated as they are entered, by on-screen prompting, thus minimising errors early on in the process. The incentives for introducing remote data entry are therefore improved data quality, speed and flexibility of access to data, automatic avoidance of simple errors and early notification of error trends, which are all factors that can expedite time to database closure.
- QUOTE: Traditionally, data capture has meant manual entry of data by trained specialist data entry operators who input data from a paper case record form (CRF) onto a central database via pre-set data entry screens, using a conventional keyboard. Data entry might occur only once (single entry) or successively (double entry), the latter with input by a second, separate data entry operator. Double entry aims to increase accuracy by highlighting the differences between the two operators' versions of the data. Reconciliation between the two entries may be achieved by either of two - methods. On-line data point to data point verification by the second, more experienced data entry operator calls for a judgement to be made between the two conflicting entries, or flagging of the discrepancy for further invetigation by CDM staff. An alternative is to run a report after double data entry which compares the two entries and indicates the inconsistencies. Subsequent comparison of the non-matching variables must then be accomplished by CDM staff before the data are transferred to the production area of the database. This represents an additional, time-consuming step in the data entry process (...)