To participate in clinical trials in the field of drug research, you need a valid GCP certificate in addition to your medical qualifications. The validity period depends on several variables, which we explain below.
Which GCP course do I need?
Period of validity of a GCP certificate
As a general rule, it is recommended to attend a GCP course every two to three years. Because the content of the course depends on your role in a clinical trial and your prior experience, different formats of GCP courses exist. The courses prepare students for a variety of clinical trial roles.
GCP courses for physicians
If you are a physician actively involved in a clinical trial, you must always provide evidence of having completed a basic GCP course (8 h) for physicians. This applies regardless of the particular study and your function.
If you are working as a study group leader, an additional GCP advanced training (8 h) is required. If you have already completed a basic GCP course two to three years ago and have not actively participated in a clinical trial in the meantime, it is advisable to complete a GCP refresher course.
GCP courses for study nurses and non-physician members of a study group
These fixed regulations do not apply to non-physician members of a site team. Nevertheless, a GCP certificate is often required as part of the sponsor’s quality management, for example, as a proof of qualification of a study nurse.
Interactive and free training advisor
Our training consultant provides helpful guidance on which course meets the requirements for your professional situation. The specifications of the German Medical Association for the curriculum for GCP training are taken into account by the training consultant.
After answering the short questions, you will immediately receive the results and learn whether a GCP Fundamentals Course, GCP Advanced Course, GCP Refresher Course, GCP Update Course, or Study Nurse Course is recommended.
GCP Curriculum of the German Medical Association
The German Medical Association, together with committees of the ethics committees, has been publishing recommendations for curricular training since 2013
- for the implementation of GCP courses (Good Clinical Practice)
- for AMG courses
- for ISO 14155 trainings and
- Trainings for MPDG (Medizinprodukterecht-Durchführungsgesetz, formerly MPG – Medical Devices Act)
The curriculum of the training courses are aimed at physicians who are involved in clinical trials. The courses that comply with these recommendations are usually recognized by ethics committees. As a training provider for GCP (and other clinical research courses), we naturally follow the latest version for our courses.
Updated specifications for GCP courses
The curriculum for GCP courses has been updated and clarified several times in recent years. The last Announcement of the German Medical Association on the curriculum for auditors, principal investigators and members of an audit team took place in the May 2022 and was published on the website of the German Medical Association. The curriculum for the current training was issued in April 2022 by the Executive Board of the German Medical Association, acting on the recommendation of the Standing Conference of the Executive Boards and the Chairpersons of the Ethics Committees of the State Medical Associations. It was adopted by the Working Group of Medical Ethics Committees in the Federal Republic of Germany.
The validity of the GCP certificate in practice
In principle, it can be assumed that the ethics committees follow the recommendations of the German Medical Association and that a GCP certificate would thus be valid for three years.
However, the final decision on the recognition of the GCP certificate is made independently by the respective ethics committee. In practice, it has therefore proven useful to refresh the GCP certificate every two years – regardless of your activity in studies. This also corresponds to the common practice in our Contract research organization GCP-Service International. All our employees renew their GCP certificate at least every two years. In the event of changes in the law, the refresher may also be required at an earlier date.
Advantages of regular refreshing of the GCP certificate
Detached from the consideration of legal requirements, you will benefit from regular refreshments of your GCP certificate as part of quality assurance.A GCP refresher is also mandatory in case of legal changes. Therefore, our recommendation is to take a GCP refresher training every two years.
Who needs a GCP certificate?
In addition to physicians, other persons involved in clinical trials also require a valid GCP certificate as part of the sponsor’s quality assurance. This serves as proof that legal, scientific and ethical standards are being met. Here you can learn more about the ICH-GCP regulations.
Who requires a GCP certificate?
All relevant stakeholders in clinical research require the appropriate GCP knowledge. These include ethics committees, sponsors, contract research organizations (CROs), and hospitals where studies are conducted.
Use our free online training advisor to test within two minutes which GCP training meets your specific needs:
Interactive and free training advisor
Our training consultant provides helpful guidance on which course meets the requirements and your professional situation. The specifications of the German Medical Association in the curriculum for GCP training are taken into account in the training advisor.
