Request for clinical trial insurance & commuting accident insurance

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* = Pflichtfeld / Required field

1General information

2Trial

3Risks

4Comments & Consent

5Review

Policyholder & Sponsor

Name of the policyholder of the clinical trial*

Please enter the name of the company to be insured

Test

Address of the policyholder*

Street Address ZIP City Country

Website of the policyholder

Is this company also a sponsor of the trial?*

Yes

Sponsor name*

Adresse des Sponsors*

Street Address ZIP City Country

Website of the sponsor

About you*

Vorname Nachname

Phone number*

Email*

Are you the legal representative of the company?*

Yes

What is your position in the undersigned company?

Name of the legal representative*

Vorname Nachname

Study layout

Study title, protocol no. and EUDRA CT no. / DIMDI no.*

Title/designation of the clinical trial or research study – including protocol number and EUDRA CT number (for AMG studies) or DIMDI number (for MPG studies)

Planned start date of the trial.*

TT Punkt MM Punkt JJJJ

Estimated completion date of the trial*

TT Punkt MM Punkt JJJJ

Clinical Trial Stage*

III

not defined

What is the general subject area of this study?*

e.g. cancer, heart, circulation, vascular system, neurology, gynecology, etc.

Expected number of persons to be insured in the study

Total number*

Please indicate the total number of patients or subjects expected to be screened for this study (i.e. including expected screening failures)

of which “screening failures”*

Expected number of "screening failures" = persons who do not meet the requirements for study participation according to a dedicated initial examination.

of which placebo patients*

Age of the study participants

Minimum age (years)*

Maximum age (years)*

Is it a multinational trial?*

Yes

Is the same study protocol also conducted abroad, i.e. is it a multinational trial?

Countries*

Country

# of patients in this country

Please enter the number of patients expected to be screened per country (i.e. including expected screening failures). Click on the plus sign to add another country

In which country is the trial being conducted?

Duration of use / treatment for the test person or patient*

Has a trial protocol been or is being created?*

Yes

Is there a follow-up treatment/observation?*

Yes

How long does the follow-up treatment take?

Which ethics committee has been/will be involved?

The trial is subject to insurance coverage according to:*

AMG

MDR/MPDG

not subject to compulsory insurance

Would you like to receive a quote for commuting accident insurance?*

Yes

Would you like to receive a quote for TrialPlus insurance reporting?*

Nein

You can find out more about reporting here

Commuting accident insurance

Expected number of visits of study participants to study centers

Total number of all visits (including screening failures)*

Number of visits to screening participants only (screening failures)*

Number of visits by actual study participants*

Do any of the study participants have a care level of III, IV or V?*

Yes

General risks of the study

Is there any connection in the study with any of the following substances?*

Yes

Accutane
Diethystilbestrol (DES)
L-trytophan
Phen/fen/dexfen
Phenylpropanolamine
Thalidomide
Birth control pills
Swine flu
Lead
Thimerosal
Mercury
Ephedrine
Fenfluramine
Fentermine/Dexfenfluramine
Phenylpropanolamine (PPA)
Hydrochloride
Cisapride
Diethylhexylphthalate (DEHP)
Phentermine
Kava (Piper methysticum)

Troglitazone
Latex
Bupropion
Diazepine/Oxazepine/Thiazepine
Dexfenfluramine
Risperidone
Remoxipride
Hydroquinone
HMG/CoA/reductase inhibitors
Retinoids
Fibrin acid derivatives
Potency agents
Biosimilars
Cox-2 inhibitors
Neuromuscular blockers
anticonvulsants
dopaminergic drugs
hydroxyquinoline derivatives
bisphenol A (BPA)
serotonin reuptake inhibitors / selective serotonin reuptake inhibitor products (SSRIs)

Which of these substances are used and how?*

Is the study related to one of the following?*

Yes

Products of animal origin
Oral contraceptives
Vaccines
Slimming products
Psychoactive products
Products with known teratogenicity
Products with known mutagenicity
Products with known carcinogenicity
Implants

Details on the connection with these products*

Do you have all documents and patient consent forms checked for legibility and comprehensibility according to a recognized procedure?*

Yes

e.g. the "Flesch-Kincaid Grade Level Scoring"

Is the CRO required to work in accordance with the Helsinki Declaration?*

Yes

Do all patient consent forms comply with the Helsinki Declaration?*

Yes

Do you use aids (e.g. videos) as part of the declaration of consent?*

Yes

Are vulnerable people treated in the study?*

Yes

e.g. persons with cognitive impairment or disabilities, pregnant women, persons under the age of 18, prisoners or detainees

Which vulnerable groups are treated and why?*

What risks are associated with the conduct of the clinical trial and the agents, substances or procedures used?*

AMG risks

Name of the medicinal product or active substance to be tested*

Does the study test the safety and efficacy of the drug?*

Yes

Are anti-inflammatory agents used in the study?*

Yes

Is this a bioequivalence study?*

Yes

Does the clinical trial involve xenotransplantation?*

Yes

Does the study investigate clinical, pharmacological or pharmacokinetic effects of a drug or record side effects?*

Yes

Are patients treated with xenogeneic cell therapies, gene transfer drugs or interferon during the clinical trial?*

Yes

It is not important that these medicinal products are the investigational medicinal product. It is sufficient that these medicinal products are used during the clinical trial - even if they are not trial-related.

Details on xenogenic cell therapeutics, gene transfer drugs or interferon*

Is the trial protocol submitted to a federal authority?*

Yes

With which authority and when?*

Why not?*

MDR/MPDG risks

Name/type of medical device to be tested*

Assignment of the medical device to risk classes*

Class I - low risk

Class II - medium risk

Class III - high risk

Class I – low risk: e.g. medical aids, wheelchairs, reusable surgical instruments, dressing material, patient beds, etc.

Class II – medium risk: e.g. dental materials, hearing aids, contact lenses, dental crowns, dental implants, dialysis machines, contact lens cleaners, X-ray machines, blood bags, condoms, defibrillators, respirators, etc.

Class III – high risk: e.g. active implants – pacemakers, heart catheters, heart valves, coronary stents, artificial joints, absorbable surgical sutures, breast implants, etc.

Klasse I - geringes Risiko: z. B. Gehilfen, Rollstühle, wiederverwendbare chirurgische Instrumente, Verbandsmaterial, Patientenbetten, usw.
Klasse II - mittleres Risiko: z. B. Dentalmaterialien, Hörgeräte, Kontaktlinsen, Zahnkronen, Dentalimplantate, Dialysegeräte Kontaktlinsenreiniger, Röntgengeräte, Blutbeutel, Kondome, Defibrillatoren, Beatmungsgeräte, usw.)
Klasse III - hohes Risiko: z. B. aktive Implantate - Herzschrittmacher- , Herzkatheter, Herzklappen, Koronarstents, künstliche Gelenke, resorbierbares chirurgisches Nahtmaterial, Brustimplantate, usw.)

Is the medical device an implant?*

Yes

Area in which the MP is implanted:*

Brain

Spine

Heart

other area

Klasse I - geringes Risiko: z. B. Gehilfen, Rollstühle, wiederverwendbare chirurgische Instrumente, Verbandsmaterial, Patientenbetten, usw.
Klasse II - mittleres Risiko: z. B. Dentalmaterialien, Hörgeräte, Kontaktlinsen, Zahnkronen, Dentalimplantate, Dialysegeräte Kontaktlinsenreiniger, Röntgengeräte, Blutbeutel, Kondome, Defibrillatoren, Beatmungsgeräte, usw.)
Klasse III - hohes Risiko: z. B. aktive Implantate - Herzschrittmacher- , Herzkatheter, Herzklappen, Koronarstents, künstliche Gelenke, resorbierbares chirurgisches Nahtmaterial, Brustimplantate, usw.)

Are antibiotics or anti-inflammatory drugs used in the clinical trial?*

Yes

Are monoclonal antibodies used in clinical trials?*

Yes

Are vaccines used in the clinical trial?*

Yes

Are treatments with stem cells planned in the clinical trial?*

Yes

Will surgery also be performed during the clinical trial?*

Yes

Surgery is always part of the clinical trial if it is mentioned in the trial protocol. It is not relevant whether the surgery is only performed for study-related reasons. It is not part of the clinical trial only if it is merely a requirement for the participation of the subjects in the study and must have taken place before the screening / recruitment phase.

How would you rate the health risk to the test subject from the surgery?*

as low

as medium

as severe

Is the clinical investigation conducted to verify the safety and performance of the medical device under normal conditions of use?*

Yes

Is the inspection plan submitted to a federal authority?*

Yes

With which authority and when?

Will an application be made to the federal authority to waive the approval requirement due to the low safety risk of the medical device?*

Yes

Is the clinical investigation being conducted with a view to obtaining CE marking?*

Yes

Is a CE marking already present?*

Yes

Is the clinical investigation being conducted in accordance with the approved purpose?*

Yes

Zu welcher anderen Zweckbestimmung wird die Studie durchgeführt?*

Are additional invasive or stressful examinations carried out on the patient?*

Yes

Please describe these invasive or stressful examinations*

Is a performance evaluation of an in vitro diagnostic medical device carried out in accordance with the provisions of § 24 MPG?*

Yes

Are invasive sampling or additional invasive or other stressful examinations performed on the test subjects/patients in this context?*

Yes

Please describe these invasive or stressful examinations or sample collections*

Risks of studies not subject to compulsory insurance

Is a medicinal product, substance, medical device, other product or procedure used in the clinical trial/study?*

Yes

Name/active ingredient of the administered drug, substance, medical device or other product; or name/explanation of the administered procedure*

What is the aim and purpose of this clinical trial?*

Name of principal investigator*

Vorname Nachname

What experience does the principal investigator have in conducting clinical trials/studies?*

Should knowledge be gained about the performance of the test object?*

Yes

Is the aim to gain insights into the security of the test object?*

Yes

Should findings on the safety of the test object be obtained?*

Yes

Are findings to be gained regarding the tolerability of the test object?*

Yes

Should knowledge about the therapeutic or diagnostic value be gained?*

Yes

Is a procedure used that serves to gain knowledge beyond the individual case?*

Yes

Is the study conducted in compliance with the "Declaration of Helsinki"?*

Yes

Are other medicinal products or products etc. used in the study in addition to the medicinal product, substance, medical device or other product to be tested?*

Yes

Please also indicate non-study-related medicines

Please describe these "other medicines or products"*

Comments

Your comments & further wishes

Declaration of consent

Please read the following conditions to the end (scroll all the way down) before you agree:

Data protection conditions*

Accuracy and completeness of the information provided

By submitting this form, you confirm that the statements made here are true, correct and complete.
You will answer the questions to the best of your knowledge and you alone are responsible for the accuracy and completeness of the information.

You acknowledge and agree that the insurer must rely on this information when deciding whether to accept or reject this application and provide insurance. Incorrect or incomplete information may entitle the insurer to withdraw from the contract, adjust it, terminate it or dispute it, possibly even with retroactive effect for insurance claims that have already occurred.

The information in this questionnaire becomes the basis / part of the insurance contract (§§ 16 ff of the German Insurance Contract Act VVG).

Completing this questionnaire is not a preliminary promise of cover.

Privacy Policy

By submitting this form, you consent to the personal data transmitted being stored and processed by Baerkraft GmbH for the purpose of comparison calculation, offer preparation or application, as well as being transmitted to selected insurance companies and used and processed by them.

If such personal data belongs to persons other than yourself, you confirm that you have obtained the explicit consent of these persons and authorize Baerkraft GmbH to use the information from these persons in the manner described above.

The information collected contains only standard questions that help the insurer decide whether or not to accept the conclusion of an insurance contract without or with changes.
However, it is not possible to predict before or during your request to which insurer exactly the data will be forwarded.
In any case, the data will only be forwarded to insurers with a known specialization.

The transfer of your personal data to insurers is therefore necessary for technical reasons. All such insurers are contractually obliged to treat your data confidentially. Furthermore, the insurers are not entitled to use your data for their own purposes.

Furthermore, you consent to Baerkraft GmbH receiving, processing and using the data required for the purpose of servicing your contracts from the insurers with whom you enter into a contractual relationship through the brokerage of Baerkraft.

The legal basis for the processing of your personal data for the purpose of preparing and/or implementing a contractual relationship is Art. 6 para. 1 lit. b) DSGVO (GDPR).

The data will be deleted within 12 months after they are no longer required to achieve the purpose for which they were collected or are not subject to any further legal storage requirements. In this case, the processing is restricted until the retention period has expired.

Note: As a rule, Baerkraft GmbH is subject to the special statutory documentation requirements for insurance brokers under the German Insurance Contract Act (VVG). Since you can generally claim insurance benefits for our insurance products for up to 10 years after the contract has ended, it is essential that we store your data for this period.

Disclaimer

Although Baerkraft handles your data with the utmost care in compliance with legal requirements, Baerkraft does not guarantee the loss of your data due to circumstances beyond our control.

Baerkraft GmbH also does not guarantee the timeliness, correctness, completeness or quality of the information provided by this questionnaire.
If any parts or individual formulations of these terms and conditions should fail to conform to the valid legal situation, or be no longer or not fully in conformity therewith, this shall not affect the content or validity of the remaining parts of the terms of use.

I agree to the data protection conditions

Initial information*

I confirm that I have downloaded and read the insurance broker's initial information in accordance with Section 15 VersVermV and the information in accordance with Section 60 (2) VVG.
Download initial information*

Place, date: ________________________________________________

Signature and company stamp of the applicant:

Attention: Please check your details again before submitting:

Request for clinical trial insurance & commuting accident insurance

Offers from all leading insurers. Fast and paperless.

Policyholder & Sponsor

Study layout

Commuting accident insurance

General risks of the study

AMG risks

MDR/MPDG risks

Risks of studies not subject to compulsory insurance

Comments

Declaration of consent

Summary

Mitglied seit 2013: