22  Research study folder template

Stored in the folder data/ there are two sets of folders designed to be used as a start point for data management in research and trials. I’ve found these useful for organising myself in a standardised way and the trial folders are appropriate to a trial master file.

22.0.1 Research study

fs::dir_tree(path = "data/Generic_Research_Folders/" , recurse = TRUE)
data/Generic_Research_Folders/
├── 01 Study Management
│   ├── Governance
│   └── Roles & Responsibilities
├── 02 Protocol
├── 03 ICF & Participant info
│   ├── Flyers and Information
│   └── Informed Consent Form and Informed Assent Form
├── 04 Agreements and Contracts
│   ├── Contracts
│   ├── Data Transfer Agreements
│   └── Material Transfer Agreements
├── 05 Ethics Applications and Letters
├── 06 Data Management
│   ├── Case Reporting Forms
│   ├── Data Management Plan
│   ├── Data compliance plan
│   └── Scripts and code
├── 07 Field Operations
├── 08 QC, Monitoring, SOPs
│   ├── Monitoring
│   ├── Quality Assurance
│   └── SOPs
├── 09 Meetings
├── 10 Steering committee
├── 11 Reports
└── 12 Publications

22.1 Clinical trial

fs::dir_tree(path = "data/Generic_Trial_Folders/" , recurse = TRUE)
data/Generic_Trial_Folders/
├── 01 Study Management
│   ├── Governance
│   └── Roles & Responsibilities
├── 02 Protocol
├── 03 ICF & Participant info
│   ├── Flyers and Information
│   └── Informed Consent Form and Informed Assent Form
├── 04 Agreements and Contracts
│   ├── Contracts
│   ├── Data Transfer Agreements
│   └── Material Transfer Agreements
├── 05 Ethics Applications and Letters
├── 06 Data Management
│   ├── Case Reporting Forms
│   ├── Data Management Plan
│   ├── Data compliance plan
│   └── Scripts and code
├── 06 Importation
│   ├── Importation
│   └── Technical Release
├── 07 Field Operations
├── 08 Pharmacovigilance
├── 09 QC, Monitoring, SOPs
│   ├── Monitoring
│   ├── Quality Assurance
│   └── SOPs
├── 10 Meetings
├── 11 External Monitoring
├── 12 DSMB
│   ├── DSMB Meeting Minutes
│   └── Membership
├── 13 Steering committee
├── 14 Reports
└── 15 Publications