Table 3.

Recommendations and resources for data management (PRGP chapter 3)

Recommendations

•   Build databases appropriate to the standard and goals of each research project

‐ Determine data sources and format

‐ Develop a data dictionary and codebook

‐ Develop the study database

•   Data storage should be secure and ensure participant confidentiality

‐ Limit access based on study role, use password protection and data encryption

‐ Obtain a data use agreement, if applicable

‐ Always log changes to data files with the change, reason for the change, staff making the change, and date

•   Develop a data collection process

‐ Identify data collection components

‐ Establish data and task tracking

‐ Define methods for data collection

‐ Pilot test all methods before starting enrollment

•   Promote timely data entry and ensure data accuracy

‐ Create a data flowchart

‐ Determine the data acquisition process

‐ Review data entry plan

‐ Develop a plan for data entry occurring in decentralized locations

‐ Develop a tracking system for managing the informed consent process

•   De‐identify the database by removing participant identifiers

‐ Generate a study participant identification management process

‐ Develop and maintain a key (master list) for de‐identified data

•   Establish a plan for ongoing data cleaning

•   Create and implement a data transfer protocol

Resources

•   Qualitative studies: sampling

•   Sample database planning table

•   Codebook content

•   Clinic identification scheme

•   Patient identification scheme

•   Determine participant identifiers

•   Data sharing agreement

•   Record retention scheme

•   Sample database planning table

•   Sample criteria for data access agreements

•   Sample “project‐specific” data sharing form

•   Qualitative data collection process