December 17, 2020...2:46 am

Site Source Data Questionnaire And Agreement Form

There are many aspects to consider when clinical trial documents containing sensitive patient data are sent to a sponsor or third party working on behalf of the sponsor and have been detected during inspections. Overall, patient integrity involving the processing of personal data will be respected during and after clinical trials and compliance with both clinical trial and data protection rules. The interconnection of the CRF (CRF and eCRF) pages is called, if necessary, CRF connectivity. Each CRF brochure is assigned with a unique object identifier and it is mandatory for site staff to ensure that the same ID is entered on all pages of the CRF booklet. The object ID entered consistently helps track the missing CRF pages. Fields such as protocol ID, location code, object identifier and patient cells facilitate database creation and help link crF pages to the study database. Areas such as protocol ID and visit labels are informative features because they contain brief descriptions of the study or evaluation schedule. The CRF version number is a critical field that prevents the use of an incorrect CRF page. All pages in the crF brochure must be numbered in a sequential order, which is useful for identifying queries through data validation procedures and manual checks. Page numbering not only provides site staff with a quick reference to certain pages, but also helps with the structured design of the database. Especially in the case of eCRF, it becomes difficult to recover FRCs if programming is not done correctly. CRF connectivity is essential when the Statistical Analysis Plan (SAP) is complex and these areas will be useful for statistical analysis. All the tasks of the clinical trial are ultimately the responsibility of the sponsor or investigator.

It is important to ensure that the relative distribution of tasks between the different parties is clearly defined, specifying the final responsibilities in each clinical trial. This should be carefully documented in protocol, procedures, contracts or agreements and other documents. Proper IP monitoring is needed to ensure that erroneous data is corrected in a timely manner and to implement the necessary corrective and preventive measures in the auditor`s suburbs. Some of the data requirements such as demographics, PEs, SEAs are the same between studies, so standard models of FRCs need to be developed that can be adapted accordingly. These proposals are of great help in carrying out several studies in the same field of research. These models have the same design principles that help the user easily capture the data because they know the design. Sponsors and suppliers should be aware: when electronic systems are used to produce/manipulate relevant clinical data from clinical trials or to maintain control and monitoring of clinical trials, to document the qualification process and other relevant documentation on the electronic system managed at the sponsor and enthhinaus level and at the supplier level, and where it is the promoter`s responsibility to ensure that these documents are available for inspections by GCP inspectors in Member States.