9. Subject Considerations

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them?

There is no direct prohibition on the use of digital advertisements for the digital recruitment of participants. It may be assumed that this aspect of a clinical trial will be decided on a case-by-case basis depending on the trial’s procedures and design.

It was stated at the BfArM-im-Dialog Event that digital advertisement has been used in various trials and studies for over fifteen years and is an effective method of significantly accelerating participant enrolment into clinical trials.

9.2 Vulnerable Subjects

Section 40b -Special Requirements for the Clinical Trial - under the German Medicinal Products Act, sets out the requirements to be considered for vulnerable subjects.

The EU CTR 536/2014 further states that in Article 10:

1. "Where the subjects are minors, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of pediatric expertise or after taking advice on clinical, ethical, and psychosocial problems in the field of pediatrics.
2. Where the subjects are incapacitated subjects, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of expertise in the relevant disease and the patient population concerned or after taking advice on clinical, ethical, and psychosocial questions in the field of the relevant disease and the patient population concerned.
3. Where the subjects are pregnant or breastfeeding women, specific consideration shall be given to the assessment of the application for authorization of a clinical trial on the basis of expertise in the relevant condition and the population represented by the subject concerned.
4. If according to the protocol a clinical trial provides for the participation of specific groups or subgroups of subjects, where appropriate, specific consideration shall be given to the assessment of the application for authorization of that clinical trial on the basis of expertise in the population represented by the subjects concerned.
5. In any application for authorization of a clinical trial referred to in Article 35, specific consideration shall be given to the circumstances of the conduct of the clinical trial."

9.3 Pediatrics (including whether consent from a single parent is sufficient vs. requiring both parents to sign)

Both parents are required to provide consent on behalf of a minor.

Section 40b(3) of the German Medicinal Products Act sets out requirements to be met in respect of clinical trials conducted on minors:

“3. A clinical trial may only be carried out on a minor who is able to recognize the nature, significance, and scope of the clinical trial and to direct his or her will accordingly if his or her written informed consent in accordance with Article 29 of Regulation (EU) No 536/2014 is in addition to the written informed consent given by his or her legal representative: is available. If a minor who is unable to identify the nature, significance, and scope of the clinical trial and to adjust his or her will accordingly, declares that he or she does not wish to participate in the clinical trial, or expresses this in any other way, this shall be deemed to be an express wish within the meaning of Article 31(1)(c) of Regulation (EU) No 536/2014.”

9.4 Financial Disclosures

The EU CTR 536/2014 requires the following information to be submitted at the time of submission of the dossier. Please see - Annex I. P of EU CTR 536/2014: 

“69. A brief description of the financing of the clinical trial.

70. Information on financial transactions and compensation paid to subjects and investigator/site for participating in the clinical trial shall be submitted.

71. Description of any other agreement between the sponsor and the site shall be submitted.”

In addition, the European Federation of Pharmaceutical Industry Associations (EFPIA) Code provides for disclosures in relation to clinical studies, as follows (see Annex B on page 37 of the Code), in accordance with clauses 22 & 23.

Clause 23 provides that “Research and Development ToVs in each Reporting Period must be disclosed by each Member Company on an aggregate basis. Costs related to Events that are clearly related to activities covered in this section can be included in the aggregate amount under the “Research and Development Transfers of Value” category”.

Research and Development ToVs are defined in Section 15.01 of the HCP Code as: “Transfers of Value to HCPs or HCOs related to the planning or conduct of (i) non-clinical studies (as defined in OECD Principles on Good Laboratory Practice); (ii) clinical trials (as defined in Regulation 536/2014); or (iii) NIS that are prospective in nature and that involve the collection of patient data from or on behalf of individual, or groups of, HCPs specifically for the study”.

9.5 ICF translations – Are Certificates Required? 

The national law is silent on whether or not a translation certification is required. Under normal practice, Certificates of Translations (CoTs) are not required to be submitted. However, relevant CoTs should be filed within the Trial Master File.

9.6 Subject Compensation: Is there a need for a local sponsor to be listed on the insurance certificate, the insurance certificate to cover the duration of the study, and specific minimum amounts of coverage to be specified, both for individual events occurring and in aggregate?

Please refer to Section 2.18 of this guidebook.