Log Jams
Documents specific responsibilities of parties involved in managing the study.
Delegation Log
This is an inquiry from a Sponsor or CRO (Contract Research Organization) to ascertain desire to participate as a site in a clinical trial
Site Interest Letter
This series of web pages (forms) for inputting study information utilizes “branching” technology.
eIRB
Identifies the required length of time research records must be stored.
Record Retention Policy
Study Personnel Education and Training, Notes to File, and Correspondence would be listed in this table.
Regulatory Binder Table of Contents
Used to help authenticate or verify who entered data based on handwriting.
Signature Log
On this you might provide information regarding available population and recruitment abilities.
Site Feasibility Questionnaire
These documents individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.
Essential Documents
This item covers legal responsibilities of the study site and the sponsor.
Clinical Trial Agreement (CTA)
This organization method describes filing from from latest to earliest.
Reverse Chronological Order
Confidential list of names and contact information for subjects allocated to the trial.
Subject Identification Log
Before providing the site with any proprietary information (the protocol) this must be signed.
Confidentiality Disclosure Agreement
This typically occurs after site has received first shipment of clinical supplies and prior to subject enrollment.
Study Initiation Visit
This item discloses any financial relationship or financial interests of the investigator of the study in accordance with 21 CFR 54.
Financial Disclosure Form
These items should not be filed in the Regulatory Binder.
Internal Audit Reports, Study Budgets, Financial Information, Contracts
Lists specimens collected and type of specimen.
Sample Tracking Log
Past enrollment performance and staff turnover rates are two examples of this.
Factors Affecting Site Selection
This office reviews and negotiates the terms of industry contracts between UT Southwestern Medical Center and for-profit companies (when a clinical research study will be conducted at UTSW with monetary support from the company).
Office of Clinical Research Services, Industry Trials Contracts group.
This aspect of the CTA identifies who has rights to publish about the study.
Intellectual Property
This item contains all relevant and current scientific information about the investigational product.
Investigator's Brochure
Includes the start and end dates of team members and their involvement in the study.
Delegation Log
The purpose of this type of agreement is to ensure that confidential information belonging to a party (or parties) to the agreement is protected.
Confidentiality Disclosure Agreement
This systematic review of protocol-related documents determines what costs are covered by the study sponsor, other funding sources, or third party payers.
Coverage Analysis
Fair compensation for work performed, publication rights, and compensation for injury are examples of this.
CTA Topics
You might find the CLIA and CAP certificates here.
Research Laboratory Documents