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Clinical Trial Management System Checklist

Posted by Phil on Apr 20, 2017 2:47:18 PM

Clinical trials play a significant role in health-care.  Clinical trial is an important feature of clinical research conducted by healthcare and pharmaceutical industries. The success of these trials depends of many logs, trackers, protocols, templates, essential documents and more. The studies need to be meticulously monitored, carried out with care and precision and reached to an accurate conclusion.

In today’s world of ever changing dynamic and challenging life conditions clinical trials have become very complex. These trials require a sophisticated and integrated approach that assists in calculating trial costs, regulatory risks and adhering to strict schedules. 

CTMS or clinical trial management system is specialized software used by healthcare industry, especially in biotechnology and pharmaceutical fields for clinical trials for clinical research. CTMS defines and manages all activities that are included in the long and rigorous trial process.

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It supports in planning, performing, managing, maintaining and reporting clinical trials. The system also maintains records of participant information, tracks deadlines and more. This system is very useful for researchers to conduct clinical trials that can provide information to create an effective line of treatment for diseases. Clinical trial safety depends of appropriate planning before the trial. The subject safety is ensured by correct monitoring during any trial and accurate reporting at the end to reach the correct conclusion.

Clinical Trial Management System Checklist -  Checklist of features desirable for a Clinical trial management system

Patient Management Clinical research works with a lot of personal data of the patient. The important documents required for patient management include documents like Research Patient Contact Information, Medical History, Physical Exam, Daily Temperature Log, Laboratory Specimen Collection and more.

Study Management- This mainly requires Patient Scheduler, Appointment Calendar, Adverse Events Database, Patient/Subject Visit Tracking Log, Study Drug Accountability, Screening Log and Progress Log. Vaccine Toxicity Grade Table and Maximum Allowable Total Blood Draw Volumes can also be included.

Study Associated Documents- Certain associated documents like Informed Consent Checklist, Version Control Guidelines, Running Agenda and Meeting Minutes Template, Safety Definitions for Clinical Research, Standard Operating Procedure (SOP) and Study Reports Table Template are helpful. 

General log and trackers- These include Telephone Contact Log and Meeting Template basically, but there can be more study specific requirements.

Protocols- Certain important required protocols for most trials are Clinical Trial Protocol Template, Concept Protocol and Protocol Feasibility Checklist.

Templates – Many templates are essential to manage clinical studies. These templates are Clinical Study Report Template, Consent to Contact Template and Consent to Screen Template

Finance Management- Any study needs financial planning and has a budget. For this Budget Monitoring Tool with example data are commonly required.

Essential Documents Essential Documents/Regulatory Binder- This commonly includes, Essential Documents Checklist, Trial Master File Contents List, Essential Documents Checklist - Clinical Research (Non-interventional), Essential Documents Checklist - Clinical Trial (Interventional), Essential Documents Storage Location Table Template.  Few other essential documents can be Extramural Essential Documents Binder/File Tabs (with Instructions), Extramural Essential Documents Binder/File Tabs, Financial Disclosure Form, Steps for Completing the Financial Disclosure Form and Regulatory Document History Log.

Enrolling and retaining participants, managing visits – Clinical trials work with the information on subjects or humans who volunteer to participate. For this we need Enrolment Log, Subject Identification Log Template, Subject Screening Log Template, Subject Visit Log any Trial, Subject Withdrawal and Termination Log, Pre- Screening Eligibility Check Template, Screening Procedures Records and Participant Communication Log.

Project management- This entails Trial Planning, Site Planning, Site Management, Subject Management, Study Management, Investigator Management, Grants and Payment Management and Clinical Supply Management (supply tracking) Documents.

Some studies may require, Consent Form Template - Case Report, Consent to Review Records & Contact for Participating in Research. They may also require Consent Form Template for Optional Research.   This is a general list for clinical trial or research trial.  Any specific resources or concerns need to be evaluated by experts before the trial.         

Topics: Clinical Research