04.Data collection10.Design and data coordination center - sporedata/researchdesigneR GitHub Wiki

1. Use cases: in which situations should I use this method?

The design and data coordination center plays a number of roles in a multicenter, prospective study:

1. Overall experimental or causal design
2. CRF preparation, data collection processes, and SOPs
3. Data quality and recruitment monitoring, with real-time reports and bi-annual DSMB reports
4. Analyses, including interim, effectiveness/efficacy, and heterogeneity of effect, as well as preparing presentations
5. Data security and privacy
6. Protocol manual
7. IRB submissions, oversight, and assistance throughout the study (distributing protocol changes/IRB modifications)
8. Staff training at each site, including routine communication with study sites
9. Regulatory binders
10. Adverse event monitoring and reporting to the IRB and DSMB
11. Periodic auditing reports
12. Results dissemination to different stakeholders, including language adaptation (from technical to lay; children, adults, and the elderly; international languages)

2. Input: what kind of data does the method require?

3. Algorithm: how does the method work?

Model mechanics

Describing in words

Describing in images

Describing with code

Breaking down equations

Reporting guidelines

Data science packages

Suggested companion methods

Learning materials

1. Books
2. Articles
   • Regulatory binder checklists from VCU and Mount Sinai
   • Regulatory binder assistance through Redcap
   • GCP training from NIDA

• Articles related to qualification program details for Drug Development (EMA) or Drug Development Tools (DDT).
  • DDT program
  • Qualification process for DDT
  • Guidance tool for researchers
  • EMA process for engaging in external regulatory sciences
  • Webminar - Engage with EMA

3. SporeData-specific
   • templates
   • functions

4. Output: how do I interpret this method's results?

Mock conclusions or most frequent format for conclusions reached at the end of a typical analysis.

Tables, plots, and their interpretation

5. SporeData-specific

Templates

Data science functions

References