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GCP-Basic-Training
Language: English    CME Points: 16    Modules: 8   Fee: 385.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

    The objective of this training is to provide competence in legal, ethical, and administrative as well as scientific aspects of a clinical trial.
     

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations. The online training has been accredited by the Medical Association of Bremen. 16 Continuing Medical Education points (CME) have been assigned.
     

    Instructions for participants and general conditions

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years. The biometric module was created with assistance of Prof. Dr. Dr. Jürgen Timm and Mr. Werner Wosniok of the Competence Centre for Clinical Trials Bremen. It ensures that non-statisticians understand the approach of different study designs and the principle of sample size calculation.

    The online training consists of eight modules, each lasting approx. 60 minutes:

    1. Introduction: Development of drugs and medical devices

    2. Basics of biometrics: different study designs and sample size calculation

    3. The declaration of Helsinki and the GCP guidelines

    4. GCP definitions/important GCP documents

    5. Investigator responsibilities part 1

    6. Investigator responsibilities part 2/Sponsor responsibilities/Audits

    7. Inspections and the reporting of safety-related events

    8. Current legislations & regulations on clinical trials in Europe - Regulation (EU) No 536/2014 (Clinical Trials Regulation - CTR), GDPR, Directive 2001/83/EC
       

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-8. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ICH GCP.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the eight questionnaires have not been answered correctly, the online training must be restarted.

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GCP-Refresher-Training
Language: English    CME Points: 8    Modules: 4   Fee: 220.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

    The objective of this training is to provide competence in legal, ethical, and administrative as well as scientific aspects of a clinical trial. With the The GCP Refresher Training you are able to renew you GCP certification on a regaular basis. The training provides you with all recent regulatory updates in the EU.

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations. The online training has been accredited by the Medical Association of Bremen. 8 Continuing Medical Education points (CME) have been assigned.

    Instructions for participants and general conditions

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years.

    The online training consists of four modules, each lasting approx. 60 minutes:

    1. The declaration of Helsinki and the GCP guidelines

    2. Investigator responsibilities part 1

    3. Investigator responsibilities part 2 / Sponsor responsibilities / Audits

    4. Current legislations & regulations on clinical trials in Europe - Regulation (EU) No 536/2014 (Clinical Trials Regulation - CTR), GDPR, Directive 2001/83/EC

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-4. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ICH GCP.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

Register

GCP-Study Nurse-Training
Language: English    CME Points: -   Modules: 6   Fee: 220.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course
     

    In the field of clinical research, national laws and international guidelines have been under continuous development in the past few years. However, the necessary continuing education of a very important group of people within clinical trials, the study nurses, is often neglected.

    Thereby it is well-known that the quality of study sites often depends on the excellent work of study nurses/study coordinators. Study nurses/study coordinators perform diversified and important tasks in the organisation and administration of clinical trials. Moreover they are responsible for assisting the investigator in communicating with and caring patients within clinical trials.

    This training is intended for prospective study nurses/study coordinators or for those who are already experienced but would like to know more about working correctly within clinical trials. Moreover investigators should invest in the continuing education and motivation of their study nurses/study coordinators to significantly increase the quality of study data and the efficiency in conducting clinical trials.
     

    Instructions for participants and general conditions
     

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during recent years.

    The online training consists of six modules, each lasting approx. 60 minutes:

    1. Development of pharmaceuticals & medical devices

    2. The Declaration of Helsinki & GCP Guidelines

    3. GCP definitions and important documents

    4. Investigator responsibilities part 1

    5. Investigator responsibilities part 2 / sponsor responsibility & Audits

    6. Documentation and quality control of study data
       

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-6. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ICH GCP.

    All training modules within a training course must be completed within two months. If the two month period has expired and the six questionnaires have not been answered correctly, the online training must be restarted.

Register

GCP-International-Training
Language: English   CME Points: -   Modules: 4   Fee: 170.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

    This training provides first competences about drug and medical device development in Europe. Furthermore it includes the responsibilities for investigators in clinical trials. It delivers essential knowledge for successful clinical trials. Please note that this training provides only a general overview and does not try to fulfill the requirements of German ethics committees.

    For a certified training of the German medical council please find our GCP-Basic-Training.

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations.


    Instructions for participants and general conditions
     

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years.

    The online training consists of four modules, each lasting approx. 60 minutes:

    1. Introduction: Development of drugs and medical devices

    2. Investigator responsibilities part 1

    3. Investigator responsibilities part 2 / Sponsor responsibilities / Audits

    4. Inspections and the reporting of safety-related events
       

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-4. After completing all modules and tests, the attendees can download and print the training certificate independently.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

ISO14155-Basic-Training
Language: English    CME Points: 18    Modules: 8   Fee: 385.00 € excl. 19 % Tax

 

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Register

  • Content and Objective of the Course

    In the EU member states medical devices were regulated completely different to pharmaceuticals due to different histories, economic reasons and a distinct mode of action. With the Regulation (EU) 2017/745 of April 2017 the market appoval for medical devices was streamlined. Consequently the regulations for conducting clinical trials with medical devices were updated. The objective of our training is the communication of current legal, ethical and administrative requirements as well as quality, scientific and practical aspects which are necessary for the conduct of clinical trials with medical devices in Europe. This training will support you to increase the quality of your clinical studies in accordance with the regulatory requirements.

     

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations. The online training has been accredited by the Medical Association of Bremen. 18 Continuing Medical Education points (CME) have been assigned.

    Instructions for participants and general conditions

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years. The biometric module was created with assistance of Prof. Dr. Dr. Jürgen Timm and Mr. Werner Wosniok of the Competence Centre for Clinical Trials Bremen. It ensures that non-statisticians understand the approach of different study designs and the principle of sample size calculation.

    The online training consists of eight modules, each lasting approx. 60 minutes:

    1. Introduction: development of drugs and medical devices

    2. Basics of biometrics: different study designs and sample size calculation

    3. European Legislation on clinical trials with Medical Devices (MDR)

    4. The declaration of Helsinki and ISO14155:2020

    5. Investigator responsibilities part 1

    6. Investigator responsibilities part 2 / Sponsor responsibilities / Audits

    7. Important documents of clinical studies

    8. Documentation and quality control of study data

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a video presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions that will be generated randomly from a pool of 40 - 60 questions. After each failed test, the attendees receive a new set of 15 random questions, 80% of which need to be answered correctly to pass. Three test repeats are possible after which the attendee must start the module presentation again from the beginning. The individual modules can only be processed in the order of module 1-8. After completing all modules and tests, the attendees can print the training certificate independently. The certificate contains all topics required by the Ethics Committees and Competent Authorities to prove the qualification of clinical research staff according to ISO 14155.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the eight questionnaires have not been answered correctly, the online training must be restarted.

Register

CRA-Basic-Training
Language: English    CME Points: -   Modules: 5   Fee: 275.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    One of the most important and impactful tools of quality control in clinical studies is the so called "Clinical Monitoring". Clinical Monitoring is performed by clinical monitors or Clinical Research Associates (CRAs). Since clinical Monitoring is such an essential component of clinical research the job opportunities in this sector are very high. There is a constant need to train persons with a scientific and/or pharmaceutical background to become CRAs. However, not everyone will become a happy and successful CRA, as the job is not limited to scientific or pharmaceutical knowledge, but it includes regulatory, legal and financial basics as well. Also soft skills like the handling of difficult social interactions and cultural differences, time management, and communication skills are important for an long and successful career as a CRA.

    We recommend the participation in this training to everyone with a scientific or pharmaceutical background, who has interest in the field of clinical research and monitoring in particular. Get a real overview of your workplace as a CRA. This training was created by experts with more than 17 years of experience in clinical research, clinical monitoring, and project management. It does include lots of practical topics a CRA should know and use on a daily basis. All topics are explained in detail and supported by exercises and questions. The training is suitable for everyone who wants to get an overview of the work of a monitor before, during and after a clinical study. To get an overview of the legal requirements of a clinical study, we recommend our „GCP-Basic-Training“ and our „ISO14155-Basic-Training“.

    Instructions for participants and general conditions

    The online training consists of five modules, each lasting approx. 60 minutes:

    1. Efficient Clinical Monitoring - Start-up Phase - Part 1

    2. Efficient Clinical Monitoring - Start-up Phase - Part 2

    3. Efficient Clinical Monitoring - During and after the study - Part 1

    4. Practical Exercise: The Source Data Verification

    5. Efficient Clinical Monitoring - During and after the study - Part 2

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 60 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-5. After completing all modules and tests, the attendees can download and print the training certificate independently.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

Register

IVDR-Update-Training
Language: English    CME Points: 4   Modules: 2   Fee: 170.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    With the release of the EU regulation 2017/746 (in-vitro diagnostic medical device regulation, IVDR) in May 2017 the marketing of in-vitro diagnosic medical devices (IVD's) in the EU undergo major changes. With the full application of the IVDR in May 2022 all manufacturers of IVD's have to be adapted to the new regulation and sponsors as well as trial sites have to be prepared.

    The objective of this training is to provide competence in legal, ethical, and administrative as well as scientific aspects of a clinical trial with in-vitro diagnostic medical devices. Our IVDR-Update-Training summarises the key changes with the application of the IVDR and the ISO 20916:2019 and provides you with all recent regulatory updates in the EU.

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date.

    Instructions for participants and general conditions

     

    The online training consists of two modules, each lasting approx. 60 minutes:

    1. Regulatory aspects of In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746)

    2. Clinical Operational Aspects of ISO 20916:2019

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in order. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ISO 20916.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the two questionnaires have not been answered correctly, the online training must be restarted.

Register

ISO14155-IVDR Training Bundle
Language: English    CME Points: 22   Modules: 10   Fee: 500.00 € excl. 19 % Tax

 

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  • Content and Objective of the Course

    The ISO14155-IVDR Training Bundle was developed for people who, in addition to learning the basics for clinical trials according to the Medical Device Law Implementation Act, also want to specialize in the current requirements for handling in vitro diagnostic devices. You will receive two certificates confirming your participation after the total of 10 modules in the two distinct training courses are finished.

    The objective of this training is to equip participants with the knowledge to competently handle the administrative, legal, and ethical requirements necessary to conduct clinical trials with medical devices and in vitro diagnostic devices.

    The flexibility, adaptability, and accessibility of this online training are its advantages. Users can complete a training program at their own speed and location. Additionally, they have two months to access the training at any time. Care was taken to ensure the high quality of our online training in accordance with the eLearning standards of the German Medical Association. The online training has been accredited by the Medical Association of Bremen. 22 Continuing Medical Education (CME) points have been assigned.

    Instructions for Participants and General Conditions

    We would like to briefly introduce the ISO14155-IVDR Training Bundle. The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared with the experience and expertise of the GCP-Service team. The training content serves as a practical guide and clarifies widespread issues and misunderstandings that have come up in the recent past.

    The online training consists of eight modules, each lasting approximately 60 minutes:

    ISO14155-Basic-Training

    1. Introduction: Development of Drugs and Medical Devices

    2. Basics of Biometrics: Different Study Designs and Sample Size Calculation

    3. European Legislation on clinical trials with Medical Devices

    4. The Declaration of Helsinki and ISO14155:2020

    5. Investigator Responsibilities part 1

    6. Investigator Responsibilities part 2/ Sponsor Responsibilities/ Audits

    7. Important Documents of Clinical Studies

    8. Documentation and Quality Control of Study Data

    IVDR-Update-Training

    1. Regulatory aspects of In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746)

    2. Clinical Operational Aspects of ISO 20916:2019

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 45 minutes followed by a multiple-choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approximately 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in order. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ISO 20916. All training modules within a training course must be completed within two months. If the two-month period has expired and the two questionnaires have not been answered correctly, the online training must be restarted.

Register

ISO14155-International-Training
Language: English   CME Points: -   Modules: 4   Fee: 170.00 € excl. 19 % Tax

 

​

  • Content and Objective of the Course

    The conduct of clinical studies on humans can only be justified if these are ethically appropriately planned, accomplished, evaluated and reported scientifically. In the field of clinical research, national laws, international guidelines and their implementation have been under continuous development in the past few years. It is important that all persons involved in a clinical study comply with these regulations and quality standards to obtain reliable study results.

    This training provides first competences about medical device development in Europe. Furthermore it includes the responsibilities for investigators in clinical trials. It delivers essential knowledge for successful clinical trials.

    Please note that this training provides a general overview and does not attempt to fulfill the requirements of German ethics committees. For a certified training according to the German medical council please find our ISO14155-Basic-Training.

    The advantage of this online training is the extendibility, accessibility, and suitability. Users can proceed through a training program at their own pace and at their own place. They can also access the training at any time within 2 months. The online training is always up-to-date. The training presentations are always updated according to new regulations.

    Instructions for participants and general conditions

    The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared by the GCP-Service team using its many years of practical experience. The training content serves as practical guide and clarifies ordinary issues and misunderstandings which have been developed during the recent years.

    The online training consists of four modules, each lasting approx. 60 minutes:

    1. The Declaration of Helsinki and ISO14155:2020

    2. ISO14155:2020 - Responsibilities for Investigators (Part 1)

    3. ISO14155:2020 - Responsibilities for Investigators (Part 2) and Sponsors

    4. Content of essential Study documents

    The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approx. 45 minutes followed by a multiple choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approx. 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in the order of module 1-4. After completing all modules and tests, the attendees can download and print the training certificate independently.

    All training modules within a training course must be completed within two months. If the two-month period has expired and the four questionnaires have not been answered correctly, the online training must be restarted.

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