Your SlideShare is downloading. ×
Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×

Introducing the official SlideShare app

Stunning, full-screen experience for iPhone and Android

Text the download link to your phone

Standard text messaging rates apply

Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency

112
views

Published on

Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency

Guidelines for principals on planning and evaluations of trainings,Guidelines for observational studies conducted on drugs, published by Turkish Medicine and Medical Device Agency

Published in: Health & Medicine

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
112
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
1
Comments
0
Likes
0
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 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.