Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency
The document provides guidelines for principals on planning trainings regarding good clinical practices and clinical research. It outlines basic principles such as having 40-80 participants, workshops, and technology requirements. It also describes applications for quality assurance during trainings and evaluations. Several example training programs are proposed, covering topics such as ethics in clinical trials, standardizing ethics committees, clinical research basics, monitoring, and roles of nurses, pharmacists, and others. Submissions for trainings must be made one month prior for agency approval.
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Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency
1. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
17.04.2013
1. OBJECTIVE
This document aims to provide guidance on the content and the format of the submissions that will be
done to Turkish Medicine and Medical Device Agency regarding the planned training programs about
good clinical practices and clinical research.
2.
BASIC PRINCIPLES
2.1 The participants’ number should be minimum 40 and maximum 80.
2.2 There should be at least 2 workshops according to training composition.
2.3 There should be at least one role-play video if it is appropriate for planned training
composition.
2.4 There should be a laptop with the internet connection, projector, DVD or VCD player, audio
system (including lapel microphone) at the training place.
2.5 There should be “question and answer application” supported by a computer system.
2.6 The physical place for training should be a big lounge with the table sitting arrangement and
preferred to be changed as 2 small lounges if needed.
2.7 The Training Coordinator who will be qualified to answer all kind of management and
educational questions should be assigned during the training.
3. APPLICATIONS
3.1 A Quality Assurance Responsible should be present during the training for assessing
presentation of the trainer, trainers’ ability to answers questions raised and trainers’ interest
in participants.
3.2 The expectation of participants should be questioned at the beginning of the training and
compared with the anticipated objectives.
3.3 The participants should be pre-tested to evaluate their knowledge level at the beginning of the
training
3.4 Mandatory training attendances should be planned as ¾ attendance per course
3.5 Preferably the signature of participants should be collected for each presentation, if not
possible for each session.
3.6 Each participant should be provided with a name tag, agenda of training, course notes and
also note book and a pen.
3.7 If the training is planned for more than one day, the training from previous day should be
summarized.
3.8 Before starting the advanced training session, participants should be reminded about the
content of the basic training.
3.9 Training presentations and workshops should not exceed respectively 40 minutes, and 3
hours.
4. EVALUATIONS
4.1 Training evaluation should be completed under2 titles; “the participants’ success assessment”
and “evaluation of the training program”
2. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
17.04.2013
The participants’ success assessment; the participants’ success should be evaluated
with an exam at the end of the training. Participants who have passed the exam and
whose continuation is appropriate should receive a “Certificate of Achievement”
.Participants who have failed the exam should be given a “Registration Certificate”.
4.1.2 Evaluation of the training program; In order to evaluate effectiveness of the training
program, feedbacks of the participants should be collected.
4.2 “Certificate of Achievement” and/or “Registration Certificate” should be signed by Training
Coordinator.
4.1.1
5. TRAINERS
5.1 Trainers should experts on their subjects.
5.2 Trainers who are not academics should receive the “Train the Trainer” training.
6. EXAMPLES FOR THE TRAINING PROGRAM
Below listed training programs are suggested as example. The content of the course can be
amended according to course title.
6.1 Ethical approach and considerations in clinical trials
6.1.1 Duration of the Training: It should be minimum 2, maximum 4 days
6.1.2 Target Audience: The training should be intended for Ethics Committee members and
investigators.
6.1.3 Objective: The objective of the training is to understand basic ethical approaches and
principles in clinical research.
6.1.4 It may planned as 2 modules;
The scope of Module 1: The scope of the training may include following topics;
Philosophy and historical progress of ethics in clinical research
Ethical aspects of clinical research
National legislations in clinical research
Mission, authority and responsibilities of Ethics Committees
Qualification of Ethics Committees
Composition, functions and operations of Ethics Committees
Items that make clinical research ethical
Wrong attitudes in clinical research
Conflict of interest in clinical research
Statistical evaluation in clinical research and reliability of data
Ethical approval process
Ethics Committee/ investigator relationship
The scope of Module 2: The scope of the training may include following topics;
Quality control and assurance in clinical research
Methodology in clinical trials
Statistical approaches in clinical trials
Clinical trials in Geriatric population
Source of mistakes in different types of clinical research
3. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
17.04.2013
Ethical aspects of observational studies
Problems in implementation
Use of placebo in psychiatric studies
Ethical aspects of genetic researches
Ethical approaches in clinical trials involving female subjects
Clinical trials involving healthy subjects
Pharmacovigilence and adverse events
Clinical trials in pediatric population
6.2 Training program about the standardization requirements for structuring of Ethics
Committees
6.2.1 Duration of the Training: It should be minimum 2, maximum 4 days
6.2.2 Target Audience: The training should be intended for Ethics Committee members.
6.2.3 Objective: The objective of the training is to understand basic ethical approaches and
principles in clinical research.
6.2.4 Scope; The scope of the training may include following topics;
European Union Directives, national legislations
Legal regulations in clinical trials
What is Good Clinical Practice(GCP)?
Composition, functions and operations of Ethics Committees
Qualification of Ethics Committees
Mission, authority and responsibilities of Ethics Committees
What is ethics? Bioethics and ethics in clinical research
Historical progress of ethical values in clinical research
Patient rights
Importance of Declaration of Helsinki and its parts to follow
Importance of Informed Consent Form (ICF) and evaluation of ICD during
submissions(workshop)
The need for drug development, milestones in drug development and
different phases of clinical trials
Statistical evaluation in clinical research and reliability of data
Quality Management-basic principles
Definition of “Standard Operating Procedure”, its reason for use and content
Preparation of “Standard Operating Procedure”(workshop)
Quality control and assurance in clinical research
Budgeting in clinical trials: payments to subjects and investigators
Evaluation of a submission folder (workshop)
Ethic approval process
Safety notifications in clinical research
Ethics Committee/ investigator relationship
Ethics Committee/ sponsor relationship
Conflict of interest in clinical research
6.3 Clinical Research/Basic Training Program
4. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
6.3.1
6.3.2
6.3.3
6.3.4
17.04.2013
Duration of the Training: It should be minimum 2, maximum 4 days
Target Audience: The training should be intended for investigators and sponsors.
Objective: The objective of the training is to understand basic principles of clinical
research.
:It may planned as 2 modules;
The scope of Module 1: The scope of the training may include following topics;
New Drug development process
Clinical research terminology
The duties and responsibilities of the parties involved in Clinical Trials
Observational studies
Non-Drug clinical trials terminology
Information of subjects and informed consent form
Legal regulations
Adverse event reporting
The practices of local authority in accordance with the relevant legislation
The scope of Module 2: The scope of the training may include following topics;
Clinical Trial Protocol
Investigators’ Brochure
Basic Statistical Terms
Pharmacokinetic Terms
Pharmacogenetic and Pharmacogenomic Terms
Quality Control in Clinical Trials
Protection of patients and Helsinki Declarations
Designing of Clinical Trials
Methodology in Clinical Trials (blinding, randomization etc.)
Placebo Controls in Clinical Trials
Project Management in Clinical Trials
Special parameters in clinical trials(Life Quality etc. )
Data Management(collection of the data, data entry, validation of the data
etc)
Data reliability/safety
6.4 Monitoring in Clinical Trials
6.4.1 Duration of the Training: It should be minimum 2, maximum 3 days
6.4.2 Target Audience: The training should be intended for sponsors and monitors.
6.4.3 Objective: The objective of the training is to understand basic principles of
monitoring in clinical trials.
6.4.4 Scope; The scope of the training may include following topics;
Monitoring policy
Legal regulations in clinical trials
Introduction to Good Clinical Practice(GCP)
Introduction to Good Laboratory Practice(GLP)
Quality assurance and standard operating procedures
5. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
17.04.2013
Terminology in clinical trials
Essential documents in study files
Inappropriate behavior in clinical trials
Selection and qualifications of Monitors
Monitor’s responsibilities
Reporting
Data Management(collection of the data, data entry, validation of the data
etc)
Data reliability/safety
Investigational product accountability and destruction
6.5 Clinical Research Nursing Training Program
6.5.1 Duration of the Training: It should be minimum 2, maximum 3 days
6.5.2 Target Audience: The training should be intended for clinical research nurses
6.5.3 Objective: The objective of the training is to understand basic principles of clinical
trials.
6.5.4 Scope; The scope of the training may include following topics;
Clinical research terminology
Legal regulations in clinical trials
Definition of clinical research and steps of designing clinical trials
Ethics Committees in clinical trials
Management of trial site
Clinical research nursing
Responsibilities in clinical researches
Randomization procedures and blinding in clinical trials
Source documents in clinical trials
Submission periods in clinical trials
Investigational product procedures
Study close-out
Adverse event reporting
6.6 Advanced Clinical Research Training Program
6.6.1 Duration of the Training: It should be minimum 2, maximum 4 days
6.6.2 Target Audience: The training should be intended for investigators and sponsors.
6.6.3 Objective: The objective of the training is to understand more specific topics of
clinical research.
6.6.4 Scope; The scope of the training may include following topics;
Data management in Clinical Trials
Risk Management in Clinical Trials
Finding volunteers and retention in Clinical Trials
Types of research on specific topics such as oncology trials, psychiatry trials
Evaluation of statistical data
Translational researches
6. GUIDELINES FOR PRINCIPALS ON PLANNING AND
EVALUATIONS OF TRAININGS
17.04.2013
Pharmacogenetic and Pharmacogenomic
Causality relationships in safety notifications
The scales used in research and evaluations
Protocol Writing
6.7 Clinical Research Pharmacist Training Program
6.7.1 Duration of the Training: It should be minimum 2, maximum 3 days
6.7.2 Target Audience: The training should be intended for clinical research pharmacists
6.7.3 Objective: The objective of the training is to understand basic principles of clinical
trials.
6.7.4 Scope; The scope of the training may include following topics;
Clinical research terminology
Legal regulations in clinical trials
Definition of clinical research and steps of designing clinical trials
Management of trial site
Task and responsibilities of clinical research pharmacists
Randomization procedures and blinding in clinical trials
Source documents in clinical trials
Investigational product procedures and accountability
Study close-out
Adverse event reporting
7. SUBMISSION AND APPROVAL
7.1 Submissions to Turkish Medicine and Medical Device Agency should be completed latest one
month before with the form and cover letter published in Institution’s website. The approval
for organization of the training is granted upon evaluation, to those who were found qualified.
7.2 The training should be organized in collaboration with an institution, an university or a
research and training hospital.
8. ANNULLED REGULATIONS
Guidance for Principals on Planning and Evaluations of Trainings which entered into force in
accordance with the presidency approval dated 28.05.2012 and no 48797 was abolished.
9. ENFORCEMENT
This guideline will enter into force on the date of approval.