Clinical Trials Kiosk - Center for Clinical and Translational Science

Contact

Meredith Fitz-Gerald, MSN, RN
Director, Clinical Research Support Program
mfitzgerald@uabmc.edu
205-975-2758

UAB Clinical Research Onboarding

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FDA Guidance Documents

The Belmont Report

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13 Principles of Good Clinical Practice (ICH)
(Pages 9-10)
Clinical Trials Budget Workshop

Feasibility and Recruitment

Recruitment/Retention Plan Worksheet

UAB Abbreviated Protocol Feasibility Assessment

Clinical Trial Operating Accounts

UAB Industry-Funded Clinical Trials Fees
Recruitment & Retention Toolkit

Recruitment & Retention Consultations

UAB Recruitment/Retention Plan Worksheet

UAB Abbreviated Protocol Feasibility Assessment

Recruitment & Retention Materials Toolkit
Investigator Toolkit

Clinical Investigator Training Podcast

ClinicalTrials.Gov

UAB Recruitment/Retention Plan Worksheet

UAB Abbreviated Feasibility Protocol Assessment Form

Trending in Trials Newsletter Subscription & Archive

Regulatory Start-up
Abbreviations
Responses to Commonly Asked Questions on Sponsor Feasibility Questionnaires and Pre-Site Selection Visits
Investigator Site File Table of Contents
Regulatory Start-up - Essential Documents Checklist	ICH GCP E6 – 8.2
Regulatory Start-up - IRB Submission Documents	ICH GCP E6 – 3.1.2
Regulatory Start-up - RB Submission Checklist	ICH GCP E6 – 3.1.2
Delegation of Authority Log	Use this log to document delegation of study related duties by the Principal Investigator to the study team. CH 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.
Form FDA 1572
Regulatory Maintenance
Regulatory Maintenance - Essentials Documents Checklist	ICH GCP E6 – 8.3
Regulatory Maintenance – IRB Submission Checklist	ICH GCP E6 – 3.1.2
Regulatory File Review Tool	ICH GCP E6 – 1.46, 1.47, 2.13
Corrective and Preventative Action Plan (CAPA) CAPA Plan Template
Regulatory Close-out
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
Other
eSignature via AdobeSign	21 CFR 11

Study Coordinator Toolkit

Abbreviations
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
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 Practices In Obtaining And Documenting Informed Consent	ICH GCP E6 – 2.9, 4.8
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.
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.
Protocol Deviation Log	Track protocol deviations on a deviations log. ICH GCP E6 – 4.5.3
Subject Record QA Audit Tool	ICH GCP E6 – 1.46, 1.47, 2.13
Study Close-Out Checklist	ICH GCP E6 – 8.4
Study Data	ICH GCP E6 (R1) GCP – 2.10, 1.11, 1.22, 1.51, 1.52, 4.9
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.
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.
Specimen Collection
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
Investigational Product
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
Other
eSignature via AdobeSign	21 CFR 11

Data Coordinator Toolkit

Subject Record QA Audit Tool	ICH GCP E6 – 1.46, 1.47, 2.13
Study Close-out Checklist	ICH GCP E6 – 8.4
Helpful Data Management Resources
Abbreviations List
Clinical Trial Glossary

Standard Operating Procedure (SOP) Templates

In clinical research, Standard Operating Procedures (SOPs) are intended to define a department’s (or unit’s, division’s, institution’s, etc...) standard practices and daily processes which are conducted to assure execution of research tasks in accordance with institutional, state and federal guidance. SOPs should contain enough detail to guide research staff through a particular procedure, and thereby establish uniformity in the everyday functions of the department. It should have a specific aim, but be written in a general format, to allow for easy implementation across a broad set of venues and circumstances. A UAB SOP workgroup developed template SOPs that are available for your use. These are drafts and should be tailored to your area. If you would like to request an SOP be developed, or have one to share, please contact the CCTS at This email address is being protected from spambots. You need JavaScript enabled to view it..

Read more
IND/IDE Consultation Team

IND/IDE Consultation Team
ClinicalTrials.gov

ClinicalTrials.gov
Research Seminar Series Video Archive

Budgeting

CITP on the Go

Clinical Billing

ClinicalTrials.Gov

Coordinator Resources

COVID Resources

OnCore

Patient Recruitment Resources

Regulatory

Self-Help

Team Communication

Quarterly Lunch & Learn

All Templates and Tools

Start-up
Abbreviations
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 Contacts and Vendors List	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
Regulatory Maintenance - Essentials Documents Checklist	List study team contact information and vendor information on this form.
During the Study
Regulatory Maintenance – IRB Submission Checklist	ICH GCP E6 – 8.3
Recruitment Log	ICH GCP E6 – 3.1.2
Screening And Enrollment Log - Template 1	Use this spreadsheet to track participant recruitment efforts. ICH GCP 4.2.1
Screening And Enrollment Log - Template 2 Informed Consent Process Checklist	Use this log to document identification of screens, and enrollments. ICH GCP E6 – 8.3.20, 8.3.22
Best Practices In Obtaining And Documenting Informed Consent	ICH GCP E6 – 2.9, 4.8
Participant Contact Form	ICH GCP E6 – 2.9, 4.8
Eligibility Checklist	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.
Study Visit 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)
Demographics Form	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.
Medical History Log - Template 1	Use this form to record demographic information required for protocol eligibility.
Medical History Log - Template 2 Medical History Log - Template 3 Concomitant Medications Log - Template 1	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 2 Vital Signs Measurements Form	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.
Physical Exam Form	Use the vital signs measurements form to document the participant’s vital signs.
Sample Source Document and Case Report Form	The physical exam form is used to document completion and findings of the physical exam assessment.
Participant Progress Notes	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.
Lab Requisition (UAB Research Lab(s))	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.
Specimen Tracking Log	A lab requisition should accompany specimens when transported to a UAB Research Lab.
Subject Level IP 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
Master IP Accountability Log	Use this log to document IP dispensation and accountability for each subject. ICH GCP E6 – 4.8.6
Helpful Data Management Resources	Use this log to document IP dispensation and accountability at the site level. ICH GCP E6 – 4.8.6
Protocol Deviation Log
Subject Record QA Audit Tool	Track protocol deviations on a deviations log. ICH GCP E6 – 4.5.3
Corrective and Preventative Action Plan (CAPA) CAPA Plan Template
Regulatory File Review Tool	ICH GCP E6 – 1.46, 1.47, 2.13
Regulatory Close-out - Essentials Documents Checklist	ICH GCP E6 – 1.46, 1.47, 2.13
eSignature via AdobeSign	21 CFR 11
Study Closeout
Regulatory Close-out - IRB Submission Checklist	ICH GCP E6 – 8.4
Study Close-Out Checklist	ICH GCP E6 – 3.1.2
Study Close-Out Checklist	ICH GCP E6 – 8.4