Record Keeping and Data Handling

The basic concept of record-keeping and handling of data is to record, store, transfer, and where necessary convert efficiently and accurately the information collected on the trial subject(s) into data that can be used to compile the Study Report.

4.1.  Documentation

All steps involved in data management should be documented in order to allow step-by-step retrospective assessment of data quality and study performance for the purpose of audit. Following the SOPs facilitates documentation.

Documentation SOPs should include details of checklists and forms giving details of actions taken, dates and the individuals responsible etc. 

4.2. Corrections

All corrections in the CRFs or any other study related documents should be made in a way that does not obscure the original entry.  The correct data should be inserted with the reason for the correction if such a reason is not obvious.  The corrections should carry the date and initials of the Investigator or the authorised person.

4.3. Electronic Data Processing

For electronic data processing only authorised person should be allowed to enter or modify the data in the computer and there should be a recorded trail of the changes and deletions made.  A security system should be set-up to prevent unauthorised access to the data.  If data is altered during processing the alteration must be documented and the system should be validated.  The systems should be designed to permit data changes in such a way that the data changes are documented and there is no deletion of data once it has been entered. A list of authorised persons who can make changes in the computer system should be maintained.  Adequate backup of the data should be maintained.

4.4. Validation of Electronic Data Processing Systems

If trial data are entered directly into the computer there must always be an adequate safeguard to ensure validation including a signed and dated printout and backup records.  Computerised systems – hardware as well as software - should be validated and a detailed description of their use be produced and kept up-to-date. 

4.5. Language

All written documents, information and other material used in the Study should be in a language that is clearly understood by all concerned (i.e. the Subjects, paramedical staff, Monitors etc.)

4.6. Responsibilities of the Investigator

Investigator should ensure that the observations and findings are recorded correctly and completely in the CRFs and signed by the responsible person(s) designated in the Protocol. 

Laboratory values with normal reference ranges should always be recorded on a CRF or enclosed with the CRF.  Values outside the clinically accepted reference range or values that differ importantly from previous values must be evaluated and commented upon by the Investigator.  Data other than that requested by the Protocol may appear on the CRF clearly marked as the additional findings and their significance described by the investigator.  Units of measurement must always be stated and transformation of units must always be indicated and documented.

In the medical records of the patient(s) it should be clearly indicated that the individual is participating in a clinical trial.

4.7. Responsibilities of the Sponsor and the Monitor

The sponsor must ensure that electronic data processing system conforms to the certain documented requirements for completeness, accuracy, reliability and consistent intended performance (i.e. validation).    The Sponsor must maintain SOPs for using these systems.  The Monitor should take adequate measures to ensure that no data is overlooked.  If the computer system automatically assigns any missing values – the fact should be clearly documented. 

Sponsor should safeguard the blinding, if any, particularly during data entry and processing.  The Sponsor should use an explicit Subject identification code that allows identification of all the data reported for each Subject.  Ownership of the data and any transfer of the ownership of data should be documented and intimated to the concerned party(ies). 

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Definitions, Pre-requiste for the study, Responsibilitiles, Record Keeping and Data Handline, Quality Assurance, Statistics, Special Concerns, Appendices