Standard Operating Principles (SOPs) followed in a business organization deal with the uniformly written procedures woven with detailed instructions framed to register practices, routine operations and processes. SOPs play an integral part in clinical research where the standard practices and daily process are handled for the execution of research tasks with respect to the institutional, federal and state guidance.
The major standard operating procedures in clinical data management is formed with the various phases involved in the protection and consistent maintenance of clinical data.
Data Management System
With the employment of CRF (Case Report Forms) the data specified using the study protocol or other study documents will be stored electronically along with the data elements that are to be retained upon archiving. The classification of data is made simple by assigning unique identifying ID for each participant. Data classified will be kept secure by liking the code or file participant names with their IDs. The use of customized computerized system for the purpose of protecting the data blinding system should be safeguarded on a daily basis. If any data is found inconsistent of seem to break through the system then it will be blocked and made inaccessible to the study team. Before the recruitment of the first participant, the trial team may be retained in the completion of the CRF.
Data that are stored in electronic devices will be analyzed on a timely basis to confirm the completeness of the information. Therefore, electronically stored data will be checked for consistent backup. During the trial analysis, the data used would not have any identity owing to the security. Similarly, data used in the trial management make use of minimum number of personal identifiers that are necessary for study conduct and to ensure patient safety. Removable media, laptop, and encrypted date should be kept out of option for storing personal data. Industry standard encryption mechanism or NHS net e-mail system shall be used for the purpose of encrypting the data sets before transmission. Only the Data Manager or statistician shall be allowed to access the data at the end of a trial using the data management systems file locking facility. In the absence of such facility, a snapshot will be taken for the record and analyses.
Electronic Data Capture
Entry of data and data capture would be taken care of by the properly trained personnel. The reflection of design and layout present in the data capture documents is the basic function of electronic data capture. As per the agreement with the trial team, the electronic systems should include data validation, consistency checks and range checks that ensure the good data quality. If any data anomalies or data query is found, it will be handled after the trial specific guidelines.
The rising of data queries has its part through the paper Case Report Forms (CRF). The manipulation of paper CRFs consists of version controlling and pagination that is done with effective data on each page. Paper CRF does not encourage the use of free-hand text.
Data Analyses and protection
For the analyses, the data shall be presented in an outlook that convinces the particular needs of the trial whereas; data protection should be presented in an appropriate confidential manner especially all the person-identifiable data. Quality check plays a vital role in data analyses and it should be done before and after the final analyses. The quality shall detect various glitches such as outlier checking, missing data, date checks, and any other inconsistencies. In the case where the data has to be exported for statistical analyses, the identity of an entire dataset must be hidden. Similarly, for data protection, any kind of personal data should be prohibited from transmitting loosely (in a way that the flow may cause the loss of data) and monitored to protect from the interception of any unauthorized parties.