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Data Management

Case report form

Case report form (CRF) – paper, electronic, or optical document, containing all the protocol information about each study subject for the sponsor. CRF can be developed based on a customer-provided protocol or created by Sciencefiles. Document development starts just after approval of the final version of the protocol. Annotated case report form (data format for statistical analysis) creation is discussed during the work scope determination.

Electronic case report form (eCRF)

Sciencefiles offers data management services with the use of electronic CRF (eCRF). Our eCRF is created using the OpenClinica platform, which is maintained on a server in Russia. Daily data backup is supported by the system. All the backup copies are also kept in Russia. OpenClinica access is possible through an internet browser with an encrypted connection. Data interchange is based on an HTTPS protocol. A digital encryption certificate is provided to ensure the security of all information.

OpenClinica allows differentiation of the access levels for different users; it also registers and stores all the data changes along with the personal information of users who made these changes. Patient data including lab studies cannot be deleted from OpenClinica, ensuring the information will not be lost on purpose or accidently. Everything put into the eCRF is kept there.

Data transfer from the eCRF can be performed in several ways. Export to MS Excel or CDISC ODM xml-file is the default method. For the xml-file, the md5-hash is calculated. This allows for control of the data if questions arise regarding the database.

For database finalization and closing out the SOP, either the customer or Sciencefiles can be used.

Activities for eCRF creation and use:

  • Data management plan development
  • Database specification development
  • Patient dairy creation
  • Creation of database in OpenClinica
  • Annotated eCRF creation
  • Data entry guideline development
  • Data validation plan development
  • Initiate monitor training on eCRF
  • Initiate researcher training on eCRF
  • Periodic monitor and/or researcher training on eCRF
  • eCRF user administration
  • eCRF server and database technical support
  • Data validation
  • Database query creation
  • Data coding
  • Interim data upload
  • Final data upload
Paper case report form

If an eCRF is not viable, Sciencefiles can offer a paper CRF.

Work steps:

  • Review clinical study protocol regarding essentials for development of the case report form
  • Case report form development
  • Unlimited document discussion and its finalization according to customer requirements
  • Regulatory, statistical, and common quality control of the final document
  • Proofreading before document finalization
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final document
Database development

Database development is based on customer approval of the clinical study protocol and case report form. For the database, we use licensed software: MS Excel spreadsheet, MS Access, or OpenClinica. The necessity and possibility of using a commercial directory (such as MedDRA) mediated data coding is discussed below.

Work steps:
  • Review of the clinical study protocol and case report form
  • Database development
  • Input restriction rules development, control of input data and functions
  • Database quality control by text input
  • Unlimited database discussion and its finalization, according to customer requirements
  • Initial, interim, and final teleconference during document development (as needed)
  • Unlimited storage period for the final database

Data transfer from paper case report forms

Work steps:
  • Data input by one operator (in large databases, two operators can work in parallel with subsequent data reconciliation)
  • Data input control
  • Follow-up enquiry development, considering possible incorrectness in case report forms and transferring corrections to the customer who will contact the clinical research centers and update the forms (Sciencefiles does not deal with clinical centers)
  • Database finalization
  • Database common quality control (miss out and misprint reveal)
  • Initial, interim, and final teleconference during data input (as needed)
  • Unlimited storage period for the final database