Activity Library
20 published activities across the clinical trial lifecycle
Planning
(4 activities)Research Question & Study Concept
Define the scientific question that drives the clinical trial.
Protocol Design & Feasibility
Design a scientifically rigorous and operationally feasible trial protocol.
Sponsor, Funding & Study Planning
Secure sponsorship, funding, and resources required to conduct the trial.
Study Document Development
Develop essential study documents including the ICF, IB, and site manuals.
Start-Up
(4 activities)Regulatory & Ethics Submission
Submit the protocol to regulatory authorities and ethics committees.
Site Selection, Budget & Contracts
Select investigative sites, negotiate budgets, and finalize agreements.
Database / EDC Build & UAT
Build and validate the electronic data capture system.
Site Initiation & Training
Initiate sites and train all personnel before enrollment begins.
Conduct
(7 activities)Recruitment & Screening
Identify, approach, and screen potential study participants.
Informed Consent
Obtain valid, voluntary, and documented informed consent.
Enrollment & Randomization
Enroll eligible participants and execute randomization procedures.
Study Intervention & Visit Conduct
Administer study intervention and conduct protocol-specified visits.
Data Collection
Collect accurate, complete, and timely clinical trial data.
Data Review & Query Management
Review data entries and resolve data queries promptly.
Safety Reporting & Monitoring
Report adverse events and conduct ongoing safety surveillance.
Close-Out
(3 activities)Last Patient Last Visit
Complete the final protocol visit for the last participant.
Site Close-Out & Reconciliation
Close investigative sites and reconcile all study materials.
Database Lock
Finalize and lock the clinical trial database.