• DMP/DHP- Data Handling plan or Data Management plan- see the above question about DMP
• DRP/ECS- Data Review Plan/Edit check Specifications- This will enlist the programmable checks that are incorporated in the DB to validate the data. This at a study level would also have manual checks that would be performed providing the details of frequency and other information like Reports details.
• CCG’s- CRF completion guidelines- These are used to ease the data entry and provided to sites. It gives the instructions to sites and provides the expectations about the data that needs to be captured.
• UAT plan: The user acceptance test plan gives what data needs be o to enter to validate the DB setup.
• Mock CRF- It contains all the unique CRF that will be used in the study at various visits.
• DTS/DTA: Data Transfer Specifications or agreement: This is the document, which contains the specifications on data transfer like Attributes of the field, what values are expected, Visits where data is expected, Code list values, etc apart from frequency and other details of Vendor information. It also contains how the data is transferred; like Web links, or any other transfer methods.