Standard Contract for Clinical Drug Trial
developed by the Universitätsmedizin Göttingen, Department of Legal and Fundamental Matters* )
(version of 9 January 2009)
Contract on a Clinical Drug Trial
between
Universitätsmedizin Göttingen, represented by its Board of Management, Robert-Koch-Str. 42, 37075
Göttingen (Germany)
(university)
department conducting the trial: ...
clinical investigator responsible: ....
and
[name of company]
(sponsor)
relating to the conduct of a clinical drug trial.
Introduction
The sponsor intends to conduct a clinical trial of the drug ... (contract research). The parties are aware
that before beginning this trial on humans, the trial must be notified to the authority responsible. The
sponsor undertakes to file such official notification. The trial is intended solely to obtain clinical data on
the use of the drug.
§1
Subject of this contract
(1)
The sponsor contracts the university, the director of the clinical trial and the university clinical
investigator responsible to conduct a clinical trial in compliance with the requirements laid down in
the trial protocol. The trial protocol is an integral part of this contract.
(2)
It is a necessary precondition for commencement of the trial that the current trial protocol receives
a positive vote from the ethics committee and that any reports required under the German Drugs
Act (Arzneimittelgesetz) to the authorities responsible have been submitted and that the approval
of the drugs committee responsible has been obtained.
(3)
The trial is planned to involve ... subjects, depending on the possibilities available. The sponsor
shall be given one case report form (CRF) filled out for each subject included.
Standard contract "Clinical Drug Trial", version of 9 January 2009 (English version of 9 January 2009)
*)Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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§2
Legal framework
The services to be performed in the trial shall be governed in particular by the provisions of the Drugs
Act (Arzneimittelgesetz), the Federal Data Protection Act (Bundesdatenschutzgesetz) and/or the relevant
state data protection acts (Landesdatenschutzgesetze), the recommendations contained in the ICH GCP
and the Declaration of Helsinki as amended from time to time. The parties undertake to comply with
these provisions and guidelines. The sponsor shall, before this contract is entered into, provide the
university, the director of the clinical trial and the university clinical investigator responsible with the
relevant versions of the ICH GCP and the Declaration of Helsinki.
§3
Vote of the ethics committee
(1)
Before the beginning of a specific trial project, the study documentation (in particular the results of
the pharmacotoxicological tests) shall be reviewed by an ethics committee, which is created in
accordance with federal state law (section 40 (1) of the Drugs Act). The sponsor shall ensure that
the necessary documents, including the documentation on the insurance of the subjects (insofar as
this is required), are submitted to the ethics committee responsible in each case.
(2)
Should the ethics committee have objections to the contents or the implementation of the study,
the parties shall jointly, having regard to the objective of the study, draw up suggestions for
corrections which take account of the objections expressed. Each party shall be entitled to rescind
the contract if it is not possible to obtain a positive vote from the ethics committee. In this case,
neither party shall have a claim for damages against the other party.
§4
Duties of the university
The university undertakes to create the conditions with regard to equipment and staff that are necessary
for the trial to be conducted. The contract shall have no influence on any trade or business transactions
between the parties.
§5
Conduct of the trial
(1)
The sponsor shall be responsible for the correct and timely provision of the documentation and
investigational medicinal products necessary to carry out the trial.
(2)
The director of the clinical trial and the university clinical investigator responsible undertake to carry
out the study in compliance with the trial protocol. Serious adverse events in connection with the
study shall be reported without delay to the sponsor and the ethics committee responsible in
compliance with the statutory provisions.
(3)
The university clinical investigator responsible shall
-
instruct the university staff who are involved in the trial on the course of the study as set out in
the trial protocol;
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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-
without delay, complete the CRFs in full and in compliance with the instructions in the trial
protocol and send them to the sponsor;
-
use the investigational medicinal products and where applicable the placebo products only for
their intended purpose and not for other experimental or therapeutic purposes. Products that
are not used shall be returned to the sponsor;
-
without delay notify the board of management of the Division of Human Medicine of serious
adverse events in connection with the study.
§6
Insurance for test subjects
The sponsor shall take out the test subject insurance policy laid down in the Drugs Act with an insurance
company of its choice entitled to operate within the territory governed by the Drugs Act and shall provide
the university and the ethics committee responsible with evidence of this. The extent of coverage must
be reasonably related to the risk associated with the clinical trial.
§7
Information on the trial drug
The sponsor shall inform the director of the clinical trial, the university clinical investigator responsible
and the university's drugs committee, through a scientist responsible for the pharmacotoxicological tests,
of the results of the pharmacotoxicological tests and the risks likely to be associated with the clinical trial.
§8
Instruction of test subjects
(1)
The university clinical investigator responsible shall ensure in the case of every subject, before the
subject is included in the trial, that the subject is fully informed as to the nature, meaning and
scope of the study, and shall obtain the subject's written consent to participation in the trial and to
subsequent recording of the medical data and their transfer to the sponsor, the supervisory
committee responsible or the higher federal authority responsible, as is required under section 40
(1) no. 2 of the Drugs Act. The fact that the subject has been instructed shall be recorded in the
trial protocol.
(2)
In addition, the university clinical investigator responsible shall ensure that a declaration of the
subject's consent is obtained to the passing on of the data stated in paragraph 1 above in
anonymous form to the local drugs committee responsible.
§9
Documentation
The university clinical investigator responsible shall be responsible for complete and timely
documentation of the study in accordance with the trial protocol.
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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§ 10
Monitoring
The parties shall agree between them on regular monitoring visits and audits. The university clinical
investigator responsible undertakes to discuss the course of the study with the monitor in an appropriate
form at regular intervals and to permit the monitor to inspect the documentation. Data protection
regulations shall be observed in this process.
§ 11
Duties of care and liability
(1)
The sponsor agrees to release the university, the director of the clinical trial and the clinical
investigator, and also the subordinate university staff, from all claims (including claims for lawyers'
fees) that are incurred by subjects taking part in the study or their representatives or successors in
title as a result of injury to health, death or property loss resulting from or in connection with the
conduct of the study.
(2)
The above right to release from all claims shall be excluded only if there has been an intentional or
grossly negligent breach of the obligations and written instructions of the sponsor set out in this
contract and in the trial protocol.
(3)
The liability of the university, of the director of the clinical trial, of the clinical investigator and of the
subordinate university staff to the sponsor shall be limited to the total amount of the value of the
contract.
§ 12
Impracticability of the study
Should the clinical study prove impossible to conduct or be medically indefensible by virtue of
unexpected events, the study can, after consultation with the sponsor, be terminated immediately. In this
case, the sponsor shall have no compensation claim against the university. Remuneration shall be paid
on the basis of the services already rendered. Obligations entered into by the university on the basis of
this contract from which it is unable to withdraw when the study is terminated shall be paid for up to the
earliest date on which these obligations can be terminated.
§ 13
Rights to the results obtained
All data obtained in the course of conducting the trial shall, unless otherwise provided in § 14 below, be
the property of the sponsor. The university hereby declares that it assigns all rights to the data obtained
during the trial to the sponsor, and the sponsor accepts this assignment. The rights of the university to
the patients' data contained in the patients' files shall be unaffected by this.
§ 14
Inventions
(1)
The university shall without delay inform the sponsor in writing of all inventions that are made in
connection with the subject of this contract.
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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(2)
When notice of an invention is given to the sponsor, the sponsor shall at the same time be granted
a right of first negotiation on the exclusive use or transfer of the invention or of the associated
rights (e. g. patent applications). The details shall be laid down between the parties in an additional
agreement in accordance with appropriate conditions that are customary in the industry.
(3)
The sponsor shall state in writing within four weeks after receiving such notice whether it intends to
exercise the right of first negotiation. If it exercises the right, the sponsor shall bear the costs of any
measures necessary to safeguard the rights (e. g. making a patent application to obtain priority and
similar measures). If the sponsor acts to exploit the inventions - and it is immaterial in what form
the invention is exploited - and if the university for this reason is obliged to pay
compensation/remuneration to the inventor, the sponsor shall release the university from this
obligation.
(4)
The right of first negotiation shall exist for a maximum of six months from the sponsor's receipt of
notice of invention. If no agreement is reached in this period, the university shall be at liberty to
exploit the invention in another way. If an invention is exploited, the sponsor shall have the right,
before the contract is awarded to a third party, to be awarded the contract itself on making an offer
in the same amount.
(5)
The inventor shall retain a non-exclusive right to use his or her employment invention in its
teaching and research activities.
§ 15
Publications
Notwithstanding the above provisions, the director of the clinical trial and the clinical investigator
responsible shall be permitted after the end of the study to publish the scientific findings achieved for
non-commercial purposes. At least sixty days before the intended publication, the sponsor shall be
provided with a manuscript of the publication for review, to give it an opportunity to comment.
Professional notes and suggestions for changes shall be taken into account insofar as they have a firm
scientific basis and are not arbitrary.
§ 16
Confidentiality
(1)
The university, the director of the clinical trial and the clinical investigator undertake to preserve
confidentiality even after the end of this contract with regard to the data, information, results and
findings obtained under the trial protocol in the course of conducting the study. This shall not affect
the right of publication granted above. If it is a question of findings that are already known or
generally available knowledge, there shall also be no duty of confidentiality. The same shall apply if
the disclosure of secrets to authorities or to other third parties is laid down by statute or judicially
ordered.
(2)
The sponsor undertakes to observe secrecy to the extent set out in paragraph 1 above with regard
to all information obtained through the university.
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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§ 17
Remuneration
(1)
The parties agree on the following remuneration: ....
(2)
The remuneration stated in paragraph 1 above shall be without value-added tax. The sponsor shall
therefore increase the remuneration by the amount of value-added tax payable.
(3)
The sponsor undertakes to make payments within thirty days after they are due.
§ 18
Term and premature termination
(1)
This contract shall begin on ... and end on ... .
(2)
The parties shall be entitled to terminate the study for a substantial reason. In the case of
termination, an invoice shall be prepared on the basis of the services already rendered. Obligations
entered into by the university on the basis of this contract from which it is unable to withdraw when
the study is terminated shall be paid for up to the earliest date on which these obligations can be
terminated.
§ 19
Governing law
This contract shall be governed exclusively by German law. The place of jurisdiction is Göttingen.
§ 20
Severability clause
If one of the provisions of this contract should be or become ineffective, this shall not affect the
effectiveness of the other contractual provisions. The ineffective provision shall be replaced by a
provision that is legally admissible and corresponds most closely to the purpose of the ineffective
provision.
_____________________________________
(authorized to represent the company)
_____________________________________
(Prof. Dr. Cornelius Frömmel)
- Member of the Board, research and teaching -
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten
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_____________________________________
(Barbara Schulte)
- Member of the Board, economic management
and administration -
_____________________________________
(Clinical investigator responsible)
Standard form of contract "Clinical drug trial", version of 9 January 2009 (English version of 9 January 2009)
Universitätsmedizin Göttingen, Stabsabteilung Rechts- und Grundsatzangelegenheiten