Start-up

Clinical Trials Glossary 

Glossary of Medical Terms in Lay Language 

Responses to Commonly Asked Questions on Sponsor Feasibility Questionnaires and Pre-Site Selection Visits

Protocol Feasibility Assessment Tool

Use this tool to assess overall feasibility of conducting the protocol.  The tool prompts the PI and study team to assess major factors needed to successfully conduct the study.  Factors such as protocol complexity, access to target population, recruitment capability, staffing resources, and projected budget needs are assessed.

ICH CGP E6 – 4.2

Recruitment and Retention Plan Tool

Use this tool as part of pre-study activities to assess adequate access to the target population, to document the site’s plan for recruitment and retention of participants, and to properly budget for recruitment and retention activities.

ICH GCP E6 – 4.2.1

Investigator Site File Table of Contents

Regulatory Start-up - IRB Submission Documents

ICH GCP E6 – 3.1.2

Regulatory Start-up - IRB Submission Checklist

ICH GCP E6 – 3.1.2

Regulatory Start-up - Essential Documents Checklist

ICH GCP E6 – 8.2

Form FDA 1572

Delegation of Authority Log

Use this log to document delegation of study related duties by the Principal Investigator to the study team.

 ICH CGP E6 – 4.1.5

FDA Guidance for Industry – Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects October 2009, Section III.A.1

Study Staff Training Log

Use this log to document study trainings (i.e., protocol training, amendment training, IP training, etc.)

ICH GCP E6 4.2.4

FDA Guidance for Industry – Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects October 2009, Section III.A.2

Study Contacts and Vendors List

List study team contact information and vendor information on this form.

During the Study

Regulatory Maintenance - Essentials Documents Checklist

ICH GCP E6 – 8.3

Regulatory Maintenance – IRB Submission Checklist

ICH GCP E6 – 3.1.2

Recruitment Log

Use this spreadsheet to track participant recruitment efforts.

ICH GCP 4.2.1

Screening and Enrollment Log - Template 1

Screening and Enrollment Log - Template 2

Use this log to document identification of screens, and enrollments.

ICH GCP E6 – 8.3.20, 8.3.22

Informed Consent Process Checklist

ICH GCP E6 – 2.9, 4.8

Best Practice in Obtaining and Documenting Informed Consent

ICH GCP E6 – 2.9, 4.8

Participant Contact Form

The participant contact form is used for easy access to the participant’s contact information.  Review the form with the participant periodically to ensure information is still current.  Update as needed.

Eligibility Checklist

The eligibility checklist is used to document the investigator’s confirmation that the participant is eligible to enroll in the study.

ICH GCP E6: 5.18.4(c)(ii), 5.18.4(i)

Study Visit Checklist

Checklist of visit-specific tasks, activities, and procedures to be conducted before, during, and after the study visit.  The visit checklist is not a case-report form (CRF) or source document.  It is a tool to remind study coordinators of protocol and site specific procedures necessary to ensure a smooth visit flow.

Demographics Form

Use this form to record demographic information required for protocol eligibility.

Medical History Log - Template 1

Medical History Log - Template 2

Medical History Log - Template 3

Use a medical history log to document past diagnoses, signs and symptoms, and surgeries or procedures the participant experienced prior to screening. 

Concomitant Medications Log - Template 1

Concomitant Medications Log - Template 2

Use a concomitant medications log to record prescription drugs, over the counter drugs, supplements, and illicit drugs taken by the participant at trial entry and throughout the duration of the trial.

Adverse Event Log - Template 1

Adverse Event Log - Template 2

Adverse Event Log - Template 3

Use the Adverse Event (AE) Log to record and track adverse event information.

Vital Signs Measurements Form

Use the vital signs measurements form to document the participant’s vital signs.

Physical Exam Form

The physical exam form is used to document completion and findings of the physical exam assessment.

Sample Source Document and Case Report Form

The case report form and source document template is used to record participant data collected during the study.  Because data to be collected is protocol driven, it is imperative to use the protocol, schedule of activities, and other protocol related documents when creating the form.  Sections of the form that include source data must be signed by the person collecting the data.

Participant Progress Notes

Progress notes are narrative notes documenting details of participant interactions, phone calls, clinical status, noncompliance, and other noteworthy information about the participant during study participation. 

Lab Requisition (UAB Research Lab(s))

A lab requisition should accompany specimens when transported to a UAB Research Lab. 

Specimen Tracking Log

Use the Specimen Collection Tracking Log for specimens shipped to an outside lab.

UAB Outreach Lab Research Protocol Request (Green Sheet)

UAB Hospital Labs – LABSOURCE

Subject Level IP Log

Use this log to document IP dispensation and accountability for each subject.

ICH GCP E6 – 4.8.6

Master IP accountability Log

Use this log to document IP dispensation and accountability at the site level.

ICH GCP E6 – 4.8.6

Helpful Data Management Resources

Protocol Deviation Log

Track protocol deviations on a deviations log.

ICH GCP E6 – 4.5.3

Corrective and Preventative Action Plan (CAPA)

CAPA Plan Template

Subject Record QA Audit Tool

ICH GCP E6 – 1.46, 1.47, 2.13

Regulatory File Review Tool

ICH GCP E6 – 1.46, 1.47, 2.13

eSignature via AdobeSign

21 CFR 11

Study Closeout

Regulatory Close-out - Essentials Documents Checklist

ICH GCP E6 – 8.4

Regulatory Close-out - IRB Submission Checklist

ICH GCP E6 – 3.1.2

Study Close-Out Checklist

ICH GCP E6 – 8.4