Data Entry - Services

Data Entry CAB staff provide the indicated data entry services and deliverables in the following two service categories:

Testing of Data Entry into Database

•    Data Entry Testpack Development
•    Entry of Testpack Data
•    Data Entry Guideline Development

Data Entry

•    CRF Tracking
•    Clinical Data Entry

The following is a description of these services and deliverables:

Data Entry Testpack Development: 

Client provides CAB with a blank casebook for the study.  CAB builds the testpack using dummy data to fill out the CRF’s.  Once the testpack is built, data entry is tested by entering the testpack data into a test environment.  

 Entry of Testpack Data: 

Both first entry and second entry (verification) of testpack data is done to ensure that all phases of entry work properly.  This process ensures that the database is designed to match the CRF’s, field for field.  Any data questions or database issues get forwarded to the Client.  When issues are resolved, the issues are retested and the Client is notified that testing is complete.

 Data Entry Guideline Development: 

While testing the database, the Project Specific Data Entry Guidelines are developed.  These guidelines list the rules, procedures, and processes that will be used in performing data entry.  Any data questions or database issues get forwarded to the Client.  When issues are resolved, additions are made to the Project Specific Guidelines and then the guidelines are sent to the Client for review and approval.  

 CRF Tracking:

 Tracking of Paper CRF’s

• Paper CRF’s are shipped to CAB from the Client with a transmittal form indicating which subjects/pages have been sent.
• CAB verifies that the pages received match the transmittal form.
• CAB then faxes the transmittal form to the Client to indicate receipt of these pages.
• The paper CRF’s are then logged into a CAB tracking database.  This database tracks the project, the date of receipt, the patient number, number of pages per patient, and completion date.
• CAB uses this database to keep track of all pages processed. 

 

   Clinical Data Entry: 

Clinical data entry consists of double entry and verification performed in two methodologies:  first entry with second entry (verification), or first and second pass entry with independent verification.  During verification, the verifier makes the final decision on what data actually stays in the database.  They ensure that all of the rules and guidelines have been adhered to.  Only the most experienced data entry staff are used for data entry verification.