1) MKK, CCRA sertifikası

2 Weeks
Maximum Allowed Duration: 3 Months
Expected Effort: 12 hours/week

A Clinical Research Associate (MKK) klinik deneyleri ve araştırma çalışmalarını izleyen bir profesyoneldir.

Sertifikalı Klinik Araştırma Görevlisi Eğitiminin Faydaları & Sertifikasyon:

Sponsorlar, CROs and other agencies involved in the implementation of clinical trials and other forms of medical research are increasingly looking for qualified individuals who have completed formal and approved training and certification in order to be able to rely on them to perform the tasks assigned to them.

CRA Training & Certification Program Structure:

Upon registering for the CRA Training and Certification program, members are granted access to the NBScience learning and certification platform.   The online CRA Training & Qualification Program is a 24-hour standardized program that provides core clinical study learning. These are some of the important areas in which training is received after the qualification curriculum has been signed.

giriiş:

This study module, which consists of several lectures and presentations, introduces the participant to the pharmaceutical and clinical research industry.

It also allows for a thorough overview of the clinical research field and the development and developments that have led to the current clinical research environment. The Introductory Module also teaches individuals about clinical research stakeholders and the Principles of Good Clinical Practice (GCP). Technologies in the management of clinical trials are discussed in detail, and comprehensive knowledge of the major clinical research regulatory bodies that exist globally is also provided to individuals.

Drug Development:

This program consists of multiple lectures and includes instruction on the pre-clinical development of drugs and biologics, different stages of clinical drug development, design of clinical trials and endpoints in clinical trials.

Ethics in Drug Development:

Each series, consisting of multiple lectures, discusses the concept of ethics in clinical research, the Informed Consent Process, Evidence and HIPAA, and also offers instruction at the International Conference on Harmonization (BEN).

Regulations in Clinical Research:

This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, Ve 814.

Roles & Sorumluluklar:

It is important to identify the roles of all stakeholders in the management of clinical trials so that standards that are realistic can be established. Each section provides a comprehensive overview of the roles of clinical practitioners, sponsors, suppliers and the Institutional Review Boards (IRB).

Temel Belgeler:

Essential records are documents which, individually and collectively, make it possible to assess the conduct of the trial and the quality of the data generated. These records provide proof of the investigator’s compliance, support and evaluation with the Good Clinical Practice guidelines and all relevant regulatory requirements.

One of the most important and frequent inspection findings during investigator site inspections is the inadequacy of reliable and accurate source reporting. This is also the most common pitfall found during sponsor audits. To order to ensure that the results of the study are focused on reliable and relevant data, the value of good documentation practice needs to be stressed for the investigator sites. This curriculum focuses on the core principles of good data practice, offers intensive training to key areas such as source documentation, main documents, IND & NDA Requirements and the Clinical Study Report (CSR).

Study Start-Up:

Each section provides an overview of clinical procedures in the start-up phase of a clinical trial. A Study Start-Up Group, vendors and sites identified and activated, procedures established for data collection and reporting, and regulatory approvals obtained shall be established from the final procedure to the first patient visit. The program offers focused instruction in areas such as feasibility evaluation, site selection, pre-study visit, site initiation, recruitment and retention of participants, the TMF (Test Master File) and budgeting of clinical trials.

Study Monitoring & Close Out:

The monitor is responsible for “surveillance the conduct of a research project.” Research monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned research protocols. A major part of the reporting duties is to inform and assist sites in compliance with FDA and other local and international regulations and/or recommendations, while also helping them meet the requirements of specific research studies. Monitors act both as communication channels between sites and sponsors and as supervisors for individual research projects. This program offers extensive training in areas such as regular site monitoring, CRF analysis and source data verification, product transparency and compliance, site closure, writing accurate monitoring reports and follow-up visit letters, and record archiving and maintenance.

Safety Reporting:

One of the CRA’s most important priorities is to ensure that clinical inspectors are fully aware of and comply with their responsibility for reporting adverse events. To do it, the CRA must often notify investigators of the criteria for adverse event reporting. Sonuç olarak, the CRA must be aware of both the regulatory and sponsor-specific criteria for reporting significant and non-serious adverse events in clinical trials. It requires the proper use and completion of adverse event forms and criteria and conditions for reporting adverse events that may go further than the regulatory requirements. Each program offers instruction in the identification and monitoring of adverse and serious adverse events in clinical trials.

Role of Quality Assurance & Data Management:

Each program offers relevant training in quality assurance (KG) audits and testing, electronic data and signatures, information management and biostatistics..

2) Araştırmacılar ve CRA'lar için GCP kursu

3) Denetçiler için GCP kursu

(aşağıya bakın veya detaylı bilgi için tıklayın Burada) 

GCP eğitim müfredatı

(1) GCP eğitimi

ICH-GCP international guidelines

 1: giriiş

1.1 Arka plan

1.2 GCP nedir?

1.3 Yeni GCP Kılavuzu

1.4 ICH GCP İlkeleri

1.5 Bazı Genel Noktalar

1.6 Dokümantasyon ve Versiyon Kontrolü

1.7 Kalite güvencesi

2: Yetkili Makamlar (CA) ve Bağımsız Etik Komite (IE)

2.1 Responsibilities of the CA

2.2 Responsibility of the IE

2.3 Konu Bilgilendirilmiş Onam Formları (ICF)

2.4 Kompozisyon, Fonksiyonlar, Operasyonlar, Procedures and Record

3: Investigat

3.1 Araştırmacının Sorumlulukları

3.2 Araştırmacı Nitelikleri ve Anlaşmaları

3.3 Yeterli Kaynak

3.4 Deneme Deneklerinin Tıbbi Bakımı

3.5 Communication with IRB/IE

3.6 Protokole Uyum

3.7 Investigational Medicinal Produc

3.8 Rastgeleleştirme Prosedürleri ve Körlemenin Kaldırılması

3.9 Araştırma Deneğinin Bilgilendirilmiş Onayı

3.10 Kayıtlar ve Raporlar

3.11 Duruşmanın Zamanından Önce Sonlandırılması veya Ertelenmesi

3.12 İlerleme Raporları ve Nihai Rapor(S) Araştırmacılar tarafından

3.13 Arşivleme

3.14 Klinik araştırma yönetiminde elektronik sistemlerin kullanımına ilişkin hususlar

3.15 Elektronik kayıtlar ve EMR'lerin klinik araştırmalarda kullanımına ilişkin güncellenmiş bilgiler.

4: Sponsorun Sorumlulukları

4.1 Kalite Güvencesi ve Kalite Kontrol

4.2 Kontrat Araştırma Organizasyonu

4.3 Deneme Tasarımı

4.4 Deneme Yönetimi, Veri İşleme ve Kayıt Tutma

4.5 Araştırmacı Seçimi

4.6 Finansman

4.7 Notification/ Submission to Regulatory Authoritie

4.8 Gaining CA approval in the

4.9 Confirmation of Review by IRB

4.10 IM hakkında bilgi

4.11 Üretme, Ambalajlama, Labelling and Coding Investigational Product

4.12 Supplying and Handling Investigational Product

4.13 Kayıt Erişimi

4.14 Denetim ve Denetim

4.15 Uyumsuzluk

4.16 Duruşmanın Zamanından Önce Sonlandırılması veya Ertelenmesi

4.17 Klinik Deneme/Çalışma Raporu

4.18 Çok Merkezli Deneme

5: Monitörün Sorumlulukları

5.1 Bu Bölüm Hakkında

5.2 giriiş

5.3 İzleme

6: Emniyet & Olumsuz Olay Raporlaması

6.1 Advers İlaç Reaksiyon Raporlaması

7: Klinik Araştırma Protokolü ve Değişiklik

7.1 Denemenin Amaçları ve Amacı

7.2 Deneme Tasarımı

7.3 Konu Seçimi ve Geri Çekilmesi

7.4 Konunun Tedavisi

7.5 Etkililiğin Değerlendirilmesi

7.6 Güvenlik Değerlendirmesi

7.7 İstatistik

7.8 Kaynak Verilere/Belgelere Doğrudan Erişim

7.9 Etik

7.10 Finansman ve Sigorta

7.11 Yayın Politikası

8: Araştırmacı Broşürü

9: Temel Belgeler

9.1 Arşivleme

9.2 Çalışma Öncesinde Bulundurulması Gereken Belgeler

9.3 Çalışma Sırasında Eklenmesi Gereken Belgeler

9.4 Çalışma Sonrası Eklenecek Belgeler

10  Örnek

10.1 İyiliğin pratik örnekleri (ve fakir!) klinik araştırmanın yürütülmesine ilişkin uygulama

I-GCP (E6-R2) uluslararası yönergeler