Having professionals specialized in the field of Clinical Trial Monitoring is essential to achieve positive results"

The Postgraduate certificate in Clinical Trial Monitoring has been designed with the objective of providing education to professionals in this important area of research, since, if this process is not carried out correctly, it will not be possible to determine the validity of the results.  

Thanks to this specialization, the student will know in depth the protocol from which the whole clinical trial is developed, as well as the development of the monitoring, establishing the most common protocol deviations and specifying solutions for specific cases. 

Relevant aspects such as the follow up visit and the closing visit, essential documents and source documents, or how to work, in daily practice, with the use of data collection notebooks, among other aspects, will also be analyzed. 

In short, a global vision of the monitoring process is presented, so that pharmacists will be able to increase their skills and abilities in this field, so that they will be able to participate in this type of research, contributing their full value as professionals. In addition, this Postgraduate certificate has the advantage of being developed in a 100% online format, so it will be the students themselves who distribute their study time as they wish, being able to combine it with the rest of their daily obligations. 

Expand your knowledge through this Postgraduate certificate that will allow you to specialize until you achieve excellence in this field"

This Postgraduate certificate in Clinical Trial Monitoring contains the most complete and up to date educational program on the market. The most important features include: 

• The development of case studies presented by experts in Clinical Trial Monitoring
• The graphic, schematic, and practical contents with which they are created, provide scientific and practical information on the disciplines that are essential for professional development
• New developments in Clinical Trials Monitoring
• Practical exercises where self assessment can be used to improve learning
• Special emphasis on innovative methodologies in Clinical Trial Monitoring
• Theoretical lessons, questions to the expert, debate forums on controversial topics, and individual reflection assignments
• Content that is accessible from any fixed or portable device with an internet connection

This Postgraduate certificate is the best investment you can make in the selection of a refresher program for two reasons: in addition to updating your knowledge in Clinical Trial Monitoring, you will obtain a degree from the leading online university in Spanish: TECH”  

The teaching staff includes professionals from the engineering sector, who bring their experience to this specialization program, as well as renowned specialists from leading societies and prestigious universities. 

The multimedia content, developed with the latest educational technology, will provide the professional with situated and contextual learning, i.e., a simulated environment that will provide immersive learning programmed to train in real situations. 

This program is designed around Problem Based Learning, whereby the professional must try to solve the different professional practice situations that arise throughout the program. To do so, the professional will be assisted by an innovative interactive video system created by renowned and experienced experts in the field of Clinical Trial Monitoring.   

Do not hesitate to take this training with us. You will find the best teaching material with virtual lessons” 

This 100% online Postgraduate certificate will allow you to combine your studies with your professional work while increasing your knowledge in this field” 

The structure of the contents has been designed by the best professionals in research and health, with an extensive background and recognized prestige in the profession, backed by the volume of cases reviewed, studied and diagnosed, and with extensive mastery of new technologies. 

This Postgraduate certificate contains the most complete and up to date scientific program on the market”  

Module 1. Monitoring of Clinical Trials (I)

1.1. Promoter I

1.1.1. General Aspects
1.1.2. Promoter Responsibilities

1.2. Promoter II

1.2.1. Project Management
1.2.2. Non-commercial Research

1.3. Protocol

1.3.1. Definition and Content
1.3.2. Protocol Compliance

1.4. Monitoring

1.4.1. Introduction
1.4.2. Definition
1.4.3. Monitoring Objectives
1.4.4. Types of Monitoring: Traditional and Risk-Based

1.5. Clinical Trial Monitor I

1.5.1. Who can be a Monitor?
1.5.2. CRO: Clinical Research Organization
1.5.3. Monitoring Plan

1.6. Clinical Monitor II

1.6.1. Monitors Responsibilities
1.6.2. Verification of Source Documents Source Documents Verification (SDV)
1.6.3. Monitors Report and Monitoring Letter

1.7. Selection Visit

1.7.1. Researcher Selection
1.7.2. Aspects to take into Account
1.7.3. Suitability of Facilities
1.7.4. Visit to other Hospital Services
1.7.5. Deficiencies in Study Facilities and Staffing

1.8. Start Up in a Clinical Research Center

1.8.1. Definition and Functionality
1.8.2. Essential Documents at the Beginning of the Trial

1.9. Initiation Visit

1.9.1. Objective
1.9.2. Preparing the Initiation Visit
1.9.3. Investigators File
1.9.4. Investigator Meeting

1.10. Hospital Pharmacy Initiation Visit

1.10.1. Objective
1.10.2. Investigational Drug Management
1.10.3. Controlling Temperature
1.10.4. General Deviation Procedure

Module 2. Monitoring of Clinical Trials (II) 

2.1. Follow Up Visit  

2.1.1. Preparation

2.1.1.1. Letter Confirming the Visit
2.1.1.2. Preparation

2.1.2. Center Development

2.1.2.1. Documentation Review
2.1.2.2. SAEs
2.1.2.3. Inclusion and Exclusion Criteria
2.1.2.4. Collate

2.1.3. Research Team Training

2.1.3.1. Monitoring

2.1.3.1.1. Monitoring Report Preparation
2.1.3.1.2. Issue Tracking
2.1.3.1.3. Team Support
2.1.3.1.4. Monitoring Letter

2.1.3.2. Temperature

2.1.3.2.1. Adequate Medication
2.1.3.2.2. Reception
2.1.3.2.3. Expiration
2.1.3.2.4. Dispensing
2.1.3.2.5. Setting Up
2.1.3.2.6. Return
2.1.3.2.7. Storage
2.1.3.2.8. Documentation

2.1.3.3. Samples

2.1.3.3.1. Local and Central
2.1.3.3.2. Types
2.1.3.3.3. Temperature Registration
2.1.3.3.4. Calibration/Maintenance Certificate

2.1.3.4. Meeting with the Research Team

2.1.3.4.1. Signature of Pending Documentation
2.1.3.4.2. Discussion of Findings
2.1.3.4.3. Re-Training
2.1.3.4.4. Corrective Actions

2.1.3.5. Review of ISF (Investigator Site File)

2.1.3.5.1. Clinical Investigations (Cis) and Protocols
2.1.3.5.2. New Approvals from the Ethics Committee and the AEMPS
2.1.3.5.3. LOGs
2.1.3.5.4. Site Visit Letter
2.1.3.5.5. New Documentation

2.1.3.6. Suspected Unexpected Serious Adverse Reactions (SUSARs)

2.1.3.6.1. Concept
2.1.3.6.2. Principal Investigator Review

2.1.3.7. Electronic Notebook

2.2. Close Out Visit

2.2.1. Definition 
2.2.2. Reasons for Close-Out Visits

2.2.2.1 Completion the Clinical Trial
2.2.2.2. Not Complying with Protocol
2.2.2.3. Not Complying with Good Clinical Practices
2.2.2.4. At the Investigators Request
2.2.2.5. Low Recruitment

2.2.3. Procedures and Responsibilities

2.2.3.1. Before the Close-Out Visit
2.2.3.2. During the Close-Out Visit
2.2.3.3. After the Close-Out Visit

2.2.4. Pharmacy Close-Out Visit
2.2.5. Final Report
2.2.6. Conclusions

2.3. Queries Management Database Slicing

2.3.1. Definition
2.3.2. Queries Rules
2.3.3. How are Queries Generated?

2.3.3.1. Automatically
2.3.3.2. By the Monitor
2.3.3.3. By an External Reviewer

2.3.4. When are Queries Generated?

2.3.4.1. After a Monitoring Visit
2.3.4.2. Close to Closing a Database

2.3.5. “Query” Status

2.3.5.1. Open
2.3.5.2. Pending Revision
2.3.5.3. Closed

2.3.6. Database Slicing

2.3.6.1. Most Frequent Database Slicing Errors

2.3.7. Conclusions

2.4. AE Management and SAE Notification

2.4.1. Definitions

2.4.1.1. Adverse Events “Adverse Event” (AE)
2.4.1.2. Adverse Reactions (AR)
2.4.1.3. “Serious Adverse Event ”(SAE) or Serious Adverse Reaction (SAR)
2.4.1.4. Suspected Unexpected Serious Adverse Reaction (SUSAR) (SUSAR)

2.4.2. Data to be Collected by the Researcher
2.4.3. Collection and Assessment of the Safety Data Obtained in the Clinical Trial

2.4.3.1. Description
2.4.3.2. Dates
2.4.3.3. Unraveling
2.4.3.4. Intensity
2.4.3.5. Actions Taken
2.4.3.6. Causality Relationship
2.4.3.7. Basic Questions

2.4.3.7.1. Who Notifies, What is Notified, Who is Notified, How are they Notified, When are they Notified?

2.4.4. Procedures for the Communication of AE/AR with Investigational Drugs

2.4.4.1. Expedited Notification of Individual Cases
2.4.4.2. Periodic Security Reports
2.4.4.3. “Ad hoc” Security Reports
2.4.4.4. Annual Reports

2.4.5. Special Interest Events
2.4.6. Conclusions

2.5. Clinical Research Associate (CRA) Standard Operating Procedures Standard Operating Procedures (SOP)

2.5.1. Definition and objectives
2.5.2. Writing a SOP

2.5.2.1. Procedure
2.5.2.2. Format
2.5.2.3. Implementation
2.5.2.4. Review

2.5.3. SOP Feasibility and Site Qualification Visit

2.5.3.1 Procedures

2.5.4. SOP Initiation Visit

2.5.4.1. Procedures Prior to the Initiation Visit
2.5.4.2. Procedures During the Initiation Visit
2.5.4.3. Monitoring Initiation Visit Procedures

2.5.5. SOP Monitoring Visit

2.5.5.1. Procedures Prior to the Monitoring Visit
2.5.5.2. Procedures During the Monitoring Visit
2.5.5.3. Monitoring Letter

2.5.6. SOP for Close-Out Visit

2.5.6.1. Preparing the Close-Out Visit
2.5.6.2. Manage the Close-Out Visit
2.5.6.3. Monitoring After a Close-Up Visit

2.5.7. Conclusions

2.6. Quality Assurance Audits and Inspections

2.6.1. Definition
2.6.2. Legal Framework
2.6.3. Types of Audits

2.6.3.1. Internal Audits
2.6.3.2. External Audits or Inspections

2.6.4. How Prepare an Audit
2.6.5. Principal Findings
2.6.6. Conclusions

2.7. Protocol Deviations

2.7.1. Criteria

2.7.1.1. Non-Compliance with Inclusion Criteria
2.7.1.2. Compliance with Exclusion Criteria

2.7.2. International Classification of Functioning (ICF) Deficiencies

2.7.2.1. Correct Signatures on Documents (CI, LOG)
2.7.2.2. Correct Dates
2.7.2.3. Correct Documentation
2.7.2.4. Correct Storage
2.7.2.5. Correct Version

2.7.3. Out-Of-Window Visits
2.7.4. Poor or Wrong Documentation
2.7.5. The 5 Rights Medication Administration

2.7.5.1. Right Patient
2.7.5.2. Right Drug
2.7.5.3. Right Time
2.7.5.4. Right Dose
2.7.5.5. Right Route

2.7.6. Missing Samples and Parameters

2.7.6.1. Missing Samples
2.7.6.2. Parameter Not Performed
2.7.6.3. Sample Not Sent On Time
2.7.6.4. Time of Sample Collection
2.7.6.6. Request for Kits Out of Time

2.7.7. Information Privacy

2.7.7.1. Information Security
2.7.7.2. Reporting Security
2.7.7.3. Photo Security

2.7.8. Temperature Deviations

2.7.8.1. Register
2.7.8.2. Inform
2.7.8.3. Act

2.7.9. Open Blinding at the Wrong Time
2.7.10. PI Availability

2.7.10.1. Not Updated in Interactive Voice Response Services (IVRS)
2.7.10.2. Not Sent on Time
2.7.10.3. Not Registered on Time
2.7.10.4. Broken Stock

2.7.11. Forbidden Medication
2.7.12. Key & Non-key

2.8. Source and Essential Documents

2.8.1. Features
2.8.2. Source Documents Location
2.8.3. Source Document Access
2.8.4. Source Document Types
2.8.5. How to Correct a Source Document
2.8.6. Source Document Retention Time
2.8.7. Main Components of the Medical History
2.8.8. Investigator’s Brochure (IB)        

2.9. Monitoring Plan

2.9.1. Visits
2.9.2. Frequency (F)
2.9.3. Organisation
2.9.4. Confirmation
2.9.5. Site Issues Categorization
2.9.6. Communication with Researchers
2.9.7. Research Team Training
2.9.8. Trial Master File
2.9.9. Reference Documents
2.9.10. Electronic Notebooks Remote Review
2.9.11. Data Privacy
2.9.12. Center Management Activities

2.10. Data Collection Notebooks

2.10.1. Concept and History
2.10.2. Timeline Compliance
2.10.3. Data Validation
2.10.4. Management of Data Inconsistencies or “Queries”
2.10.5. Data Exports
2.10.6. Security and Roles
2.10.7. Traceability and Logs
2.10.8. Report Generation
2.10.9. Notifications and Alerts
2.10.10. Electronic Notebook vs. Paper Notebook

A unique, key and decisive training experience to boost your professional development”