Clinical Trial Initial Submission to MREC

Regulatory Documentation

Investigator's brochure

Clinical trial protocol

Informed consent form (ICF)

Case report forms (CRFs)

Investigational medicinal product details

Drug labeling

Certificates of analysis (CoA) for the investigational product

Regulatory approval from other countries (if applicable)

Ethics Committee Submission

Cover letter to the ethics committee

Application form for ethics committee review

Clinical trial protocol

Informed consent form (ICF)

Investigator's brochure

Case report forms (CRFs)

Investigational medicinal product details

Drug labeling

Certificates of analysis (CoA) for the investigational product

Regulatory approval from other countries (if applicable)

Site Documentation

Site feasibility assessment

Site-specific protocol

Curriculum vitae (CV) of the principal investigator and study team members

Investigator's agreement form

Financial disclosure form

Laboratory accreditation certificates

Facilities and equipment details

Standard operating procedures (SOPs) for various activities

Pharmacy license (if applicable)

Insurance coverage details

Patient Recruitment and Safety

Patient recruitment plan

Advertisements and recruitment materials

Safety reporting plan

Adverse event reporting forms

Serious adverse event reporting plan

Data and safety monitoring board plan (if applicable)

Pharmacovigilance plan

Emergency contact details

Data Management and Quality Assurance

Data management plan

Case report form completion guidelines

Data validation plan

Quality control and quality assurance plan

Data monitoring plan

Data entry and query resolution procedures

Archiving and record-keeping procedures

Statistical Analysis and Reporting

Statistical analysis plan

Sample size calculation

Randomization and blinding procedures

Statistical software details

Data analysis plan

Interim analysis plan (if applicable)

Publication plan

Financial and Administrative

Budget for the clinical trial

Financial disclosure forms

Contracts or agreements with study sponsors or funding agencies

Clinical trial agreement

Insurance coverage details

Payment schedule and invoicing procedures

Monitoring visit schedule

Miscellaneous

Any additional documents required by the ethics committee or regulatory body

Any other relevant documents or forms specific to the clinical trial

Note: This checklist is a general guide and may vary depending on the specific requirements of the Medical Research Ethics Committee (MREC) and the nature of the clinical trial. It is important to consult the MREC guidelines and regulations for accurate and up-to-date information.