2.1 Patient population assessment: do you actually have these patients?

Evaluate site patient population against protocol inclusion and exclusion criteria using medical records, registries, and referral networks.

2.2 Resource and infrastructure evaluation: staff, space, equipment, and time

Assess site infrastructure requirements including staff availability, equipment needs, storage capacity, and aggregate time burden to determine whether your site can conduct the study properly and safely.

2.3 Competing studies and therapeutic area saturation: when your portfolio outgrows your patients

Analyze the competitive study landscape at the site level, assess therapeutic area saturation, and apply a structured accept/defer/decline framework when studies compete for the same resources and patients.

2.4 Completing feasibility questionnaires and confidential disclosure agreements

Complete feasibility questionnaires with honest, data-supported answers and understand the purpose and obligations of confidential disclosure agreements.

3.1 Understanding clinical trial budgets: revenue, cost, and the space between

Learn the structure of clinical trial budgets including per-patient payments, screen failure fees, procedure costs, and overhead calculations.

3.2 Fair market value and anti-kickback considerations

Understand fair market value principles, the federal Anti-Kickback Statute, and institutional compliance processes that govern clinical trial payments.

3.3 The contract negotiation process: what CRCs need to know

Understand the clinical trial agreement negotiation process and the CRC's role in supporting contract discussions with operational cost intelligence.

3.4 Budget tracking and financial reconciliation during the study

Track study budgets, manage invoicing milestones, and flag financial discrepancies to site management throughout the study lifecycle.

4.1 The FDA Form 1572: what it means and why it matters

Understand the significance and legal implications of FDA Form 1572, including the investigator commitments it represents.

4.2 IRB/IEC initial submission packages: assembling the complete application

Prepare a complete IRB/IEC initial submission package including all required supporting documentation, and implement a tracking system to prevent common return reasons.

4.3 Central IRB vs. local IRB: different processes, same principles

Differentiate the submission processes for central IRB review, local IRB review, and institutional-level approvals, and navigate the practical workflow differences that affect your start-up timeline.

4.4 Regulatory authority notifications and institutional requirements

Navigate regulatory authority notification requirements and site-specific institutional approvals needed before study activation.

5.1 The essential records checklist: what you need and when you need it

Compile a complete set of pre-study essential records as specified in ICH E6(R3) Appendix C.

5.2 Investigator and site staff documentation: CVs, licenses, training records, and delegation logs

Verify the currency, completeness, and accuracy of investigator qualifications documentation including CVs, medical licenses, GCP training certificates, and delegation of authority logs.

5.3 Laboratory documentation: certifications, normal ranges, and accreditation

Collect and verify the laboratory documentation required for study activation, including CLIA/CAP certifications, normal reference ranges, laboratory director credentials, and central laboratory setup records.

5.4 Sponsor-provided documents: protocol, IB, IP information, and study-specific materials

Manage the receipt, version verification, and tracking of sponsor-provided documents including the protocol, Investigator's Brochure, IP handling instructions, and study-specific materials required for site activation.

6.1 Preparing for the SIV: logistics, materials, and team readiness

Prepare a comprehensive SIV readiness package including regulatory binder completion status, team availability confirmations, physical site preparation, and a pre-SIV open items communication to the CRA.

6.2 During the SIV: your role, your questions, and what to document

Identify the six critical information domains that must be captured during the SIV, formulate operational questions the CRA may not cover unprompted, and document the visit for team reference.

6.3 Post-SIV action items: turning training into operational readiness

Create and execute a post-SIV action item tracker that ensures the site achieves activation within sponsor timelines.

6.4 From SIV to first patient: the final activation checklist

Execute a comprehensive final activation checklist verifying every regulatory, operational, and logistical requirement before first enrollment.

7.1 System access and configuration: EDC, IVRS/IWRS, and study portals

Configure and verify access to all study-required electronic systems for all authorized site personnel.

7.2 Internal workflows: establishing visit templates, order sets, and lab kits

Build visit-specific workflow templates, pre-approve standing orders, establish supply management systems, and create an internal study reference guide before the first participant arrives.

7.3 Pre-enrollment team readiness checks

Verify that every team member, system, supply, and workflow is genuinely ready before the first participant encounter -- and make the go/no-go decision with confidence.

7.4 The first enrollment: a walkthrough from identification to randomization

Walk through the complete first enrollment process from participant identification through screening, consent, eligibility confirmation, randomization, and first study visit procedures.

2.1 Patient population assessment: do you actually have these patients?

Evaluate site patient population against protocol inclusion and exclusion criteria using medical records, registries, and referral networks.

2.2 Resource and infrastructure evaluation: staff, space, equipment, and time

Assess site infrastructure requirements including staff availability, equipment needs, storage capacity, and aggregate time burden to determine whether your site can conduct the study properly and safely.

2.3 Competing studies and therapeutic area saturation: when your portfolio outgrows your patients

Analyze the competitive study landscape at the site level, assess therapeutic area saturation, and apply a structured accept/defer/decline framework when studies compete for the same resources and patients.

2.4 Completing feasibility questionnaires and confidential disclosure agreements

Complete feasibility questionnaires with honest, data-supported answers and understand the purpose and obligations of confidential disclosure agreements.

3.1 Understanding clinical trial budgets: revenue, cost, and the space between

Learn the structure of clinical trial budgets including per-patient payments, screen failure fees, procedure costs, and overhead calculations.

3.2 Fair market value and anti-kickback considerations

Understand fair market value principles, the federal Anti-Kickback Statute, and institutional compliance processes that govern clinical trial payments.

3.3 The contract negotiation process: what CRCs need to know

Understand the clinical trial agreement negotiation process and the CRC's role in supporting contract discussions with operational cost intelligence.

3.4 Budget tracking and financial reconciliation during the study

Track study budgets, manage invoicing milestones, and flag financial discrepancies to site management throughout the study lifecycle.

4.1 The FDA Form 1572: what it means and why it matters

Understand the significance and legal implications of FDA Form 1572, including the investigator commitments it represents.

4.2 IRB/IEC initial submission packages: assembling the complete application

Prepare a complete IRB/IEC initial submission package including all required supporting documentation, and implement a tracking system to prevent common return reasons.

4.3 Central IRB vs. local IRB: different processes, same principles

Differentiate the submission processes for central IRB review, local IRB review, and institutional-level approvals, and navigate the practical workflow differences that affect your start-up timeline.

4.4 Regulatory authority notifications and institutional requirements

Navigate regulatory authority notification requirements and site-specific institutional approvals needed before study activation.

5.1 The essential records checklist: what you need and when you need it

Compile a complete set of pre-study essential records as specified in ICH E6(R3) Appendix C.

5.2 Investigator and site staff documentation: CVs, licenses, training records, and delegation logs

Verify the currency, completeness, and accuracy of investigator qualifications documentation including CVs, medical licenses, GCP training certificates, and delegation of authority logs.

5.3 Laboratory documentation: certifications, normal ranges, and accreditation

Collect and verify the laboratory documentation required for study activation, including CLIA/CAP certifications, normal reference ranges, laboratory director credentials, and central laboratory setup records.

5.4 Sponsor-provided documents: protocol, IB, IP information, and study-specific materials

Manage the receipt, version verification, and tracking of sponsor-provided documents including the protocol, Investigator's Brochure, IP handling instructions, and study-specific materials required for site activation.

6.1 Preparing for the SIV: logistics, materials, and team readiness

Prepare a comprehensive SIV readiness package including regulatory binder completion status, team availability confirmations, physical site preparation, and a pre-SIV open items communication to the CRA.

6.2 During the SIV: your role, your questions, and what to document

Identify the six critical information domains that must be captured during the SIV, formulate operational questions the CRA may not cover unprompted, and document the visit for team reference.

6.3 Post-SIV action items: turning training into operational readiness

Create and execute a post-SIV action item tracker that ensures the site achieves activation within sponsor timelines.

6.4 From SIV to first patient: the final activation checklist

Execute a comprehensive final activation checklist verifying every regulatory, operational, and logistical requirement before first enrollment.

7.1 System access and configuration: EDC, IVRS/IWRS, and study portals

Configure and verify access to all study-required electronic systems for all authorized site personnel.

7.2 Internal workflows: establishing visit templates, order sets, and lab kits

Build visit-specific workflow templates, pre-approve standing orders, establish supply management systems, and create an internal study reference guide before the first participant arrives.

7.3 Pre-enrollment team readiness checks

Verify that every team member, system, supply, and workflow is genuinely ready before the first participant encounter -- and make the go/no-go decision with confidence.

7.4 The first enrollment: a walkthrough from identification to randomization

Walk through the complete first enrollment process from participant identification through screening, consent, eligibility confirmation, randomization, and first study visit procedures.