Clinical Trial Start Up

Pre-Trial Activities

Identify the need for a clinical trial

Determine the trial objectives and design

Develop a trial protocol

Obtain necessary ethical and regulatory approvals

Secure funding for the trial

Establish trial team and assign roles and responsibilities

Develop trial-specific tools and documents (e.g., case report forms, informed consent forms)

Site Selection and Initiation

Identify potential trial sites

Conduct site feasibility assessments

Select trial sites based on predefined criteria

Initiate site agreements and contracts

Conduct investigator and site staff training

Establish trial-specific infrastructure and resources at each site

Perform site initiation visits to ensure readiness

Regulatory and Ethical Compliance

Submit trial protocol and relevant documents for regulatory and ethical review

Obtain necessary approvals from regulatory bodies and ethics committees

Prepare and submit regulatory and ethics-related documents as required

Monitor compliance with regulatory and ethical guidelines throughout the trial

Trial Documentation

Develop and finalize trial-specific documentation, including the investigator's brochure, trial master file, and trial-specific standard operating procedures (SOPs)

Ensure all trial-related documents are complete, accurate, and up-to-date

Maintain trial documentation in an organized and easily accessible manner

Investigational Product Management

Obtain necessary approvals for import/export, storage, and distribution of investigational products

Establish procedures for investigational product accountability and storage conditions

Develop and implement randomization and blinding procedures, if applicable

Monitor investigational product usage and compliance at trial sites

Recruitment and Enrollment

Develop recruitment strategies and materials

Identify potential participants and screen them for eligibility

Obtain informed consent from eligible participants

Enroll participants into the trial according to predefined criteria

Monitor participant recruitment and enrollment progress

Data Collection and Management

Develop data collection tools, including case report forms

Train site staff on data collection and management procedures

Establish processes for data entry, verification, and quality control

Ensure data confidentiality and integrity

Monitor data collection and management throughout the trial

Safety Monitoring and Reporting

Develop procedures for adverse event reporting and serious adverse event reporting

Train site staff on adverse event reporting and safety monitoring

Establish a safety monitoring committee, if required

Monitor and report safety-related data and incidents throughout the trial

Ensure participant safety and welfare are prioritized

Trial Monitoring and Auditing

Develop a trial monitoring plan

Conduct routine monitoring visits to assess site compliance and data quality

Address any issues or deviations identified during monitoring visits

Coordinate external audits or inspections, if required

Trial Close-out

Develop a trial close-out plan

Ensure all data collection and monitoring activities are completed

Analyze and interpret trial data

Prepare trial reports, including final study report and publications

Archive trial documentation and ensure long-term storage and accessibility