Table 1.

World Health Organization “Good Clinical Practice” Principles: Implementation in ACTIVE and Single-Lab Studies

WHO Principle # and Description	Example Implementation in ACTIVE	Proposed Implementation in Single-Lab Studies
2. Research involving humans should be scientifically justified and described in a clear, detailed protocol	- Manual of Procedures (MOP) - Scientific rationale in MOP and introduction of design paper - Predefined analysis plans	- Lab Manual - Scientific rationale included in Lab Manual and/or Registered Report - Pre-defined analysis plans - Methods sections make transparent details of data collection and analysis
6. Research involving humans should be conducted in compliance with the approved protocol;	- Full protocol conducted in compliance with approved protocol - Detailed data management protocol, detailed manuals and scripts, standardized data forms - Communication log book	- Conduct full protocol in compliance with approved protocol - Detailed data management protocol, detailed manuals and scripts, standardized data forms - Communication channels, electronic lab notebooks, or study folder - Tablet and Computer-based Instruction
10. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s) and currently licensed to do so, where required;	- Rigorous training and certification/recertification procedures for all roles (assessment, intervention, data, coordination, test scoring; special certification for clinical procedures such as BMI, hand dynamometer, physical performance tests), checklists	- Rigorous training and certification/recertification procedures for all roles, checklists
11. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification;	- Publicly available MOP, instruments, and data (via NACDA) - Separation of data analysis role (coordinating center analysts) from PIs - DSMB reviews interim data - Pre-approval and post-review of all presentations and papers	- Make Lab Manual, instruments, data, and code publicly available - Separation of data analysis role (independent statistician); “buddy system” to check data analyses; or within-institution informal data management and oversight - Multiverse analyses, specification curves
14. Systems with procedures that assure the quality of every aspect of the trial should be implemented.	- Regular quality assurance observations (assessment, intervention, data management), including by outside parties (coordinating center, DSMB, funding agency) - 10% quality checks of all test scoring - Standardized equipment and calibration	- Regular quality assurance (utilizing checklists) - Quality checks of test and/or questionnaire scoring - Use measures for which online training and certification are available

Note. DSMB = Data safety and monitoring board; MOP = Manual of procedures; NACDA = National Archive of Computerized Data in Aging; PI = Principal Investigator; WHO = World Health Organization