Regulations concerning clinical trials of medicines for human


Date FOR-2009-10-30-1321


Ministry of Health and Care Services


Published in 2009 Booklet 12


Commencement 30/10/2009

Edited

FOR 2013-04-22-408 from 01.07.2013

Changes
FOR-2003-09-24-1202

For
Norway

Legal

LOV-1992-12-04-132-§3, LAW-1992-12-04-132-Section 28, TO-1995-06-08-521

Promulgated
03.11.2009 kl. 13.20

Short Title
Regulation on clinical testing of drugs

Chapter Overview:

Chapter 1 - General provisions (§§ 1-1 - 1-14)
Chapter 2 - Protection of trial subjects (§§ 2-1 - 2-9)
Chapter 3 - The Ethics Committee (§§ 3 -1 - 3-5)
Chapter 4 - the Norwegian Medicines Agency (§§ 4-1 - 4-5)
Chapter 5 - Rules during the trial (§§ 5-1 - 5-3)
Chapter 6 - Audit and inspection (§§ 6-1 - 6-4)
Chapter 7 - Mandatory report adverse events and adverse events (§§ 7-1 - 7-4)
Chapter 8 - Documentation (Master File) and a final report (§§ 8-1 - 8-5)
Chapter 9 - Entry into force etc. (§9-1)

Adopted by the Ministry of Health on 30 October 2009 pursuant to the Act on 4 December 1992 no. 132 relating to medicinal products, etc. (Medicines Act) § 3 and § 28 of the Act. Administrative decisions 8 June 1995 no. 521. | || EEA information: EEA agreement, Annex II, chap. XIII. 15o (Directive 2001/20 / EC) and no. 15zf (Directive 2005/28 / EC).
Changes: Amended by regulations 18 Dec 2009 No.. 1839 17 January 2013 no. 61, April 22, 2013 No.. 408.

Chapter 1 - General Provisions

§ 1-1. These regulations apply to clinical trials, including multi-center trials, Human Drug. The regulations apply testing on both patients and healthy persons.
Regulation does not investigational treatment of individual patients and non-interventional studies.
It should not be conducted clinical trials that entail modification of subject gender cell identity (germ line genetic identity).

§ 1-2. Good clinical practice and the Declaration of Helsinki All clinical trials, including bioequivalence and bioavailability studies should be planned, reported and conducted in accordance with the provisions of the regulations and standards of good clinical practice.
Clinical trials must be in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research with human beings.

§ 1-3. Basic requirements Consideration of subjects' rights, safety and welfare takes precedence over scientific and social interests.
Individuals who participate in the implementation of a clinical trial should be in the form of education, training and experience to be qualified to perform their duties.
Clinical trials should be scientifically based and guided by ethical principles.
Necessary procedures to ensure the quality of the trial shall be followed.
Available clinical and preclinical data on an investigational medicinal product shall be sufficiently comprehensive to warrant clinical trials.
All information on clinical trials recorded, processed and stored so that it be made for proper reporting, interpretation and verification of information as well as effective protection of personal data.

§ 1-4. Conditions for initiation of a clinical trial Clinical trials may only be initiated if

A)
provisions of Chapter 2 on the protection of trial subjects are met

B)
there is a pre-approval from the ethics committee under the provisions of Section 3

C)
Norwegian Medicines Agency has no objections under the provisions of Chapter 4.

§ 1-5. Definitions In these regulations:

A)

Serious adverse event or serious adverse reaction: harmful and unintended response or effect that in any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth injury;

B)

Side effect: one adverse event in a subject that has received a drug in a clinical trial where a causal relationship between the event and the drug being tested is likely or possible;

C)

Clinical research organization (CRO): a person or an organization (commercial, academic or others) who are engaged by the sponsor to perform one or more of the sponsor's trial-related duties and functions;

D)


Ethics committee, the Regional Committee for Medical Research Ethics. The Ethics Committee shall ensure that the persons participating in a clinical trial are getting the protection they are entitled to by assessing protocol, investigator qualifications, testing site suitability, and the process and the material used to inform trial subjects prior informed consent is emitted;

E)

Attempts person: a person who participates in a clinical trial and who either receive the investigational medicinal product or participating in a control group;

F)

Good clinical practice (GCP): A standard for the design, management, execution, monitoring, auditing, recording and reporting clinical trials, which ensures that data and reported results are credible and accurate, and that subjects' rights, integrity and confidentiality is protected;

G)

Principal investigator: investigator who leads the trial at the individual trial site;

H)

Non-intervention study: a study in which one or more drugs prescribed in the usual manner in accordance with the terms of the marketing authorization. A therapeutic strategy for each patient is not decided in advance by a trial protocol but falls within current practice and the prescription of medicines is clearly separate from the decision to include the patient in the study. It should not be necessary with additional procedures for diagnostic or monitoring of the patient, and epidemiological methods shall be used to analyze the collected data;

I)

Informed consent, in writing, dated and signed declaration to participate in a clinical trial provided by a person who is able to consent. A declaration voluntarily after the test person has received adequate information about the test species, importance, scope and risks. If the person is not able to consent, granted consent by the person who can consent on their behalf;

J)

Inspection: the act by a regulatory authority with a review of documents, facilities, records (records), quality assurance arrangements and any aid by the authorities as related to the trial, and that may be located on the trial, at the sponsor, and / or CRO, or at other establishments which the authorities see fit to inspect;

K)

Investigator's brochure: A compilation of the clinical and preclinical data on the investigational medicinal product (s) that are relevant to the study of the product (s) in humans;

L)

Clinical trial: any systematic study of medicinal products for human for the purpose of acquiring or testing knowledge of the effects or influence of physiological function, interactions, adverse reactions, absorption, distribution, metabolism and excretion, or to study their therapeutic value;

M)

Drug: substances, drugs or preparations etc.. as defined in the Act on 4 December 1992 no. 132 on medicines etc. § 2;

N)

Monitor: the person who will ensure that the trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures, current guidelines for good clinical practice, Norwegian law generally, and to ensure that the trial has the agreed progression;

O)

Multicenter trial: clinical trial conducted at several centers simultaneously and by the same protocol;

P)

National coordinating investigator: investigator in Norway who coordinates the Norwegian sites participating in a multicenter trial;

Q)

Protocol: a document that describes the objective, design, methodology, statistical considerations and organization of the trial. The minutes shall include a description of the subjects who may or may not participate in the clinical trial and the rules for monitoring and publishing;

R)

Protocol amendment: a written description of one or more changes, or a formal clarification of the protocol;

S)

Sponsor: a person, a company, institution or organization that is responsible for the implementation, management and / or financing of a clinical trial;

T)

Investigator: doctor or dentist who performs a clinical trial;

U)

Investigational medicinal product: A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. As the IMP are also drug marketing authorization if they are used, formulated or packaged differently than the approved formulation, or used for an unapproved indication, or to obtain further information on the commercial formulation;

V)


Unexpected side effect: an adverse reaction, the nature / or severity is not consistent with the applicable product;

W)

Adverse event: an adverse medical event in a person who has been a drug in a clinical trial, and that does not necessarily have a direct relationship with this treatment.

§ 1-6. Sponsor and investigator responsibilities under other legislation provisions in the regulations does not change the responsibility as a sponsor and the investigator may have under other legislation.
Sponsor may delegate its duties in connection with a clinical trial of an individual, business, institution or organization.
Sponsor is responsible for ensuring that the conduct of the clinical trial and the treatment of the data generated, made in accordance with the provisions of this regulation.

§ 1-7. Sponsors haunt sponsor shall be located in the EEA. This does not apply if the sponsor is represented by a representative residing in the European Economic Area. The Clerk shall demonstrate its authority to the Norwegian Medicines Agency.

§ 1-8. The investigator and sponsor investigator and the sponsor may be the same person.

§ 1-9. Financing trial substance sponsor shall ensure that the trial substance with any associated equipment be made available free.

§ 1-10. Permission to treat personal information sponsor is responsible for the existence of the necessary approval from the Ethics Committee for processing of health information in accordance with the law of 20 June 2008 no. 44 on medical and health research § 33, ref. Section 3
Personally identifiable personal data only transmitted between Norway and countries outside the EEA, if the conditions of the law of 20 June 2008 no. 44 on medical and health research § 37 are met.

§ 1-11. Investigator's brochure The information in the investigator's brochure shall be provided in a concise, simple, objective, balanced and non-advertising nature shape so that a potential investigator can make a neutral assessment of the benefit / risk ratio of the clinical trial.
Have trial substance authorization, you approved SPC (SPC) is used instead of investigator's brochure.
Sponsor validates and updates the investigator's brochure at least once a year.

§ 1-12. Transfer of title documents of ownership documents and results from a clinical trial may be transferred. Such assignment shall be in writing and a copy shall be sent to the Norwegian Medicines Agency. The new licensee is required to store and archive material according to the provision in § 8-2.

§ 1-13. Further application duty for special studies Clinical trials involving gene therapy, the use of GMOs as a drug or predictive, presymptomatic or carrier diagnostic tests must also be approved in accordance with the law on 5 December 2003 no. 100 on human medical use of biotechnology, etc.
Clinical trials with drug consisting of or containing genetically modified organisms, may involve a deliberate release of the organism and should be approved in advance by law on 2 april 1993 no. 38 on the production and use of genetically modified mechanisms mm
Clinical trials that involve the collection, storage, treatment, destruction, introduction to Norway and exportation from Norway of human biological material should be permitted by law on 20 June 2008 no. 44 on medical and health research.

§ 1-14. Manufacture and import of drugs for clinical trial manufacturing and importation of drugs for clinical trials requires permission from the Norwegian Medicines Agency.
Regulations on 2 November 2004 no. 1441 relating to the manufacture and importation of drugs applies to the manufacture and importation of drugs for clinical trials.

Chapter 2 - Protection of subjects

§ 2-1. Assessment of drug use and risk factors A clinical trial may only be initiated if:

A)
the known benefit and risk ratio is weighted in relation to the presumed benefit for the individual trial subject and other present and future patients

B)
Ethics Committee and the Norwegian Medicines Agency finds that the drug's expected benefits may justify the risk by conducting the experiment, cf. Chapter 3 and Chapter 4.

Sponsor shall attempt continuously assess whether the requirements of the first paragraph.

§ 2-2. Requirements for Informed Consent Before the trial starts, the investigator or the person chairing the information process on investigator behalf, informing the human subject on the purpose of the trial, the risks and benefits associated with the test subject's participation, conditions for completion of the trial and that the trial subject anytime withdraw from experiment.

If attempts person can not give informed consent, the information referred to in subsection given to persons who according to § 2-8 and § 2-9 can consent on the test person's behalf.
Before the trial starts, the test person consent to participation in the trial. The consent shall be given after the information in the first paragraph have been received. If written consent can not be given, the consent may be given orally. Oral consent shall be attested by an independent witness.
If attempts person can not give informed consent, the consent referred to in the previous paragraph is given by the person who according to § 2-8 and § 2-9 can consent on the test person's behalf.

§ 2-3. Withdrawal of consent Consent to participate in a clinical trial pursuant to § 2-2 may at any time be revoked. Patient data and biological material collected up to revocation, will be included in the trial data, but no further data to be collected.

§ 2-4. Insurance of subjects sponsor shall assure the subjects participating in the trial, in a satisfactory manner against any damage that may occur during the trial, cf. Act 23 December 1988 no. 104 on Product Liability.

§ 2-5. Protection of physical and mental integrity and personal data A clinical trial may only be initiated if the test person's right to physical and mental integrity and the right to privacy is respected and information regarding the trial subject are protected under the provisions of the Act 14 April 2000. 31 on the treatment of personal data, ref. law 20 June 2008 no. 44 on medical and health research § 2, third paragraph.

§ 2-6. Requirements practitioner qualifications The person responsible for treatment and decisions about treatment of subjects shall be a qualified physician or dentist.

§ 2-7. Requirements to pin test subject must be informed about a contact point where they can get further information.

§ 2-8. Clinical trials on people under 18. In addition to the requirements contained in § 2-1 to § 2-7, subject to trials on persons under 18 years informed consent from parents or others with parental responsibility. Trials on persons between 16 and 18 also requires the consent of the minor. In addition, the following conditions must be met:

A)
whoever consents have been given written and oral information about the study in accordance with § 2-2

B)
consented believed to express the minor willingness

C)
the minor has received information about the trial, the risks and benefits adjusted in relation to their ability to understand

D)
trial can be expected to give patients a direct gain

E)
trial is essential to verify data obtained through clinical testing or other testing methods to persons who are able to give informed consent

F)
trial directly concerns a clinical condition that the minor is in, or the trial is of such a nature that it can only be carried out on minors

G)
relevant policies of the European Medicines Agency (EMEA) followed

H)
trial is designed so that pain, discomfort, fear and any other risk is minimized in relation to the disease

I)
protocol approved by the Ethics Committee, with expertise in pediatrics or has obtained advice on clinical, ethical and psychosocial questions regarding pediatrics

J)
test person's interests at all times given greater weight than the scientific and societal interests.

View of subjects under 18 years of age shall count as an increasingly important determinant in line with his or her age and maturity.
Any use of inducements for minor subjects is prohibited, except compensation in connection with participation in the trial.

§ 2-9. Trials on persons without consent or with reduced consent In addition to the requirements contained in § 2-1 to § 2-7, subject to trials on persons under guardianship who has not legal capacity to consent to participation in clinical trials, that the terms of the law 2 July 1999. 63 on patient and user rights § 4-7 are met. Trials on legal person who is unable to consent because of inadequate mental powers, illness or other reasons, presupposes that the next of kin by the Act of 2 July 1999 no. 63 on patient and user rights § 1-3 letter b consents. In addition, the following conditions must be met:

A)
whoever consents have been given written and oral information about the study in accordance with § 2-2

B)
consented believed to express the test person's will, and he has not oppose the measure

C)

Test person has received information about the trial, the risks and benefits, adjusted in relation to their ability to understand

D)
there is reason to assume that the results of the trial are of direct benefit to the subject's health

E)
trial is essential to verify the data obtained through clinical testing or other testing methods to persons who are able to give informed consent, and it directly relates to a life-threatening or debilitating clinical condition that the human subject is in or the information can not be obtained on the basis of consent given in accordance with § 2-2

F)
trial entails only minimal risk and burden to the subject

G)
test person's interests at all times given greater weight than the scientific and societal interests

H)
trial is designed to pain, discomfort, fear, and any risk is minimized relative to the disease

I)
protocol approved by the Ethics Committee, with expertise in the relevant disease and the particular patient group or have obtained advice on clinical, ethical and psychosocial questions regarding the relevant disease and the particular patient group.

Chapter 3 - The Ethics Committee

§ 3-1. Application for clinical trial to the Ethics Committee Application for clinical trials submitted Ethics Committee. Before a clinical trial commences, there must be a pre-approval from the ethics committee.

§ 3-2. Ethics Committee's consideration of the application Ethics Committee shall in processing the application in particular consider the following:

A)
the clinical trial relevance and design

B)
about the supposed risks and inconvenience is weighted in relation to the benefit for the individual trial subject and other present and future patients, and the conclusion is justified

C)
protocol

D)
investigator and other personnel suitability

E)
investigator's brochure

F)
testing site suitability

G)
relevance and completeness of the consent form and information process related to obtaining informed consent

H)
grounds for research on persons not able to give informed consent

I)
provisions regarding compensation or if a subject suffers injury or dies as a result of a clinical trial

J)
insurance or compensation to cover the investigator and the sponsor's responsibility

K)
size of, and the detailed rules for the payment of any fees or any compensation to investigators and subjects

L)
relevant clauses in any intended contract between the sponsor and the trial site, and

M)
how subjects are recruited.

§ 3-3. Time periods Ethics Committee shall give its opinion to the applicant and to the Norwegian Medicines Agency within 60 days after the complete application is received.
The Ethics Committee may request seeking to supplement the application once. The deadline is suspended in such cases from the time the ethics committee sends notification to the applicant until the requested information is received.
Application concerns a clinical trial of the drug for gene therapy, somatic cell therapy or genetically modified organisms, the deadline mentioned in the first paragraph be extended once for 30 days. Is the Ethics Committee in accordance with applicable regulations required to consult an expert, can the deadline for such a drug be extended by another 90 days.
Application concerns a clinical trial that involves xenogenic cell therapy, there is no maximum time when opinion shall be given.

§ 3-4. Simple Statement by multicenter studies At multicenter studies geographically covered by several committees, consideration shall only be given one statement from one ethics committee.
By multicenter studies involving clinical testing in several EEA countries, should be given a statement of one's ethics committee in each country.

§ 3-5. Rules of procedure and document retention Each ethics committee adopts rules of procedure that ensures that tasks in § 3-1 to § 3-5 safeguarded.
Unless other rules stipulate longer storage, the Ethics Committee retain documents of significance to the individual clinical trial for at least three years after the trial ended.

Chapter 4 - The Norwegian Medicines Agency

§ 4-1. Application for clinical trial Medicines Agency Before a clinical trial initiated in Norway, application must be submitted to the Norwegian Medicines Agency.

§ 4-2. Time periods Application for commencement of a clinical trial should be treated within 60 days of submission of complete application.

Application concerns clinical trials involving gene therapy, somatic cell therapy or genetically modified organisms, the deadline mentioned in the first paragraph be extended once for 30 days. Is Norwegian Medicines Agency in accordance with applicable regulations required to consult an expert, can the deadline for such a drug be extended by another 90 days.
Application concerns a clinical trial that involves xenogenic cell therapy, there is no maximum time when the application will be processed.

§ 4-3. Norwegian Medicines Agency's decision If the Norwegian Medicines Agency has no objections against the initiation of the clinical trial, informed constantly about this.
If the Norwegian Medicines Agency has objected to the application, the applicant has the right to supplement the application once. If the application is not completed, or if the Norwegian Medicines Agency despite the change maintains the objections, application shall be deemed rejected and the trial may not be implemented. Rejection of applications for clinical trials should be justified.
If the Norwegian Medicines Agency has not made its assessment within the period stated in § 4-2, the trial may begin, provided that the ethics committee has approved the trial.
A clinical trial can not start without a written reply from the Norwegian Medicines Agency, if the trial comes:

A)
a medicinal product referred to in Part A of the Annex to Regulation (EEC) No. 2309/93

B)
a drug where the active substance is a biological product derived from animals or humans,

C)
a drug containing biological ingredients derived from animals or humans, or whose preparation requires such components,

D)
a drug for gene therapy, somatic cell therapy, including xenogenic cell therapy, or

E)
a medicinal product containing genetically modified organisms.

§ 4-4. Labelling of the investigational medicinal product Testing product should be labeled.

§ 4-5. Dispensing of drugs Unless the Norwegian Medicines Agency in connection with the application for clinical trial has determined otherwise, the trial substance dispensed from a pharmacy or individual utprøvningssted.

Chapter 5 - Rules during the trial

§ 5-1. Protocol amendments Sponsor may change the protocol after the clinical trial has been initiated.
Want sponsor to make significant changes to the protocol

A)
which may affect the subjects' safety, or

B)
which can alter the interpretation of the scientific documentation, or

C)
which is significant,

Sponsor shall notify the Norwegian Medicines Agency and the Ethics Committee. Along with the notification shall be given an explanation and a justification for the changes.
The Ethics Committee shall within 35 days after receiving a complete application, approve or reject the application according to the criteria mentioned in § 3-3. If the committee rejects the application, the sponsor may not make changes in the protocol.
Have Ethics Committee approved the application, and the Norwegian Medicines Agency does not oppose the changes within 35 days of receipt of a complete application, the sponsor may make amendments to the protocol.
Have Ethics Committee approved the application, while the Norwegian Medicines Agency has opposed the changes, the sponsor may amend the minutes if taking into account the Norwegian Medicines Agency's objections. Otherwise the sponsor withdraw amendment back.

§ 5-2. Implementation of security measures If it emerges new circumstances or information concerning the clinical trial or drug that could impact on the safety, the sponsor and the investigator immediately take the necessary security measures to prevent the subjects suffer damage.
Sponsor shall immediately inform the ethics committee and the Norwegian Medicines Agency about the changes and the measures implemented.

§ 5-3. Suspension of clinical trials Norwegian Medicines Agency can halt a commenced clinical trials, if

A)
conditions for initiation are no longer considered fulfilled

B)
new information casts doubt on the safety of the trial

C)
new information casts doubt on the scientific value of the trial.

Before Norwegian Medicines Agency makes a decision under subsection shall sponsor or investigator is given a deadline of one week to comment on the case, if such a postponement of the decision does not constitute a risk.

Chapter 6 - Supervision and inspection

§ 6-1. Regulator Norwegian Medicines Agency supervises that the provisions of these regulations are upheld.

Norwegian Board oversees health services rendered by trials, cf. Act on March 30, 1984 no. 15 Supervision of Health Care mm (Health Act). The Norwegian Medicines Agency shall, upon request from the Norwegian Board of Health information on which doctors / dentists are engaged in trials, and about conducted and planned inspections.

§ 6-2. Inspection Norwegian Medicines Agency supervises the requirement of good clinical practice are complied with in connection with the clinical trial.
Norwegian Medicines Agency may, as part of the audit conduct inspections at anyone who is or has been involved in the conduct of the trial.
Inspection can be made

A)
before, during and after completion of a clinical trial

B)
as part of the assessment of an application for authorization under Regulations 18 December 2009 No.. 1839 medicinal

C)
follow up the issue of a marketing authorization.

Inspection may be made notwithstanding the statutory duty of confidentiality, ref. Law 4 December 1992 No.. 132 on medicines etc. § 28, second paragraph.

§ 6-3. Inspection report Based on the Authority prepares the Norwegian Medicines Agency an inspection report made available to sponsor. It shall upon request be made available to the Ethics Committee, the authorities of other EEA countries and the European Medicines Agency (EMEA).

§ 6-4. GCP inspector Inspection under these regulations carried out by one or more GCP inspectors. An inspector shall

A)
have university degree or have equivalent experience in medicine, pharmacy, pharmacology, toxicology or other relevant areas

B)
have knowledge of principles and procedures related to drug development and clinical trials of medicinal

C)
have knowledge of national and international regulations concerning clinical trials of drugs and the rules concerning the issuance of authorization

D)
maintain and develop their professional qualifications

E)
be familiar with the confidentiality that applies to confidential information they become aware of through their work

F)
have knowledge of procedures and systems for recording clinical data

G)
have knowledge of the healthcare structure and legislation in the European Economic Area and in relevant third

H)
be equipped with identification showing their status as an inspector.

If the individual inspector does not meet all the requirements of the first paragraph, it is sufficient that the inspectors overall during an inspection meets the requirements.
Each inspector shall receive a document with instructions and detailed information on the duties, responsibilities and educational requirements. The document should be updated regularly.
An inspector shall sign a statement of impartiality. This statement should be considered when it is decided which inspectors shall carry out a specific inspection.

Chapter 7 - Mandatory report adverse events and adverse events

§ 7-1. Investigator duty to report adverse events The investigator shall immediately report to the sponsor all serious adverse events that occur in connection with the trial. This does not apply if the protocol or investigator's brochure stated that the serious adverse event is not subject to immediate reporting.
The immediate reports should be followed up with detailed written reports.
In the immediate and follow-up reports to the subjects identified by a personal code number.
The investigator shall, in accordance with the provisions of the Protocol to report to sponsor the adverse events and laboratory abnormalities in the protocol is considered critical for the assessment of drug safety.
By reported deaths, the investigator is obliged to transmit the sponsor and the Ethics Committee the information these demands.

§ 7-2. Sponsors obligation to retain information on adverse events sponsor shall keep detailed records of all adverse events which are reported to him by the investigator. The information shall upon request be forwarded to the Norwegian Medicines Agency.

§ 7-3. Sponsors duty to report unexpected and serious adverse events sponsor shall immediately and not later than seven days after becoming aware of an unexpected and serious adverse reaction that is fatal or life threatening, send a report to the authorities in all EEA countries. Relevant information about the further course will then be given within eight days.
Sponsor shall immediately and not later than 15 days after becoming aware of an unexpected and serious adverse reaction that is not fatal or life-threatening, send a report to the authorities in all EEA countries.

Sponsor shall inform all investigators of the trial substance suspected adverse reactions that are serious and unexpected.

§ 7-4. Annual Sponsor shall annually submit the authorities in those countries attempt progress

A)
a list of all suspected serious adverse reactions that have occurred in the relevant period, and

B)
a report of the subjects' safety.

Under subsection applies as long as the clinical trial is in progress.

Chapter 8 - Documentation (Master File) and final report

§ 8-1. The documentation for the clinical trial sponsor shall prepare and update documentation for the clinical trial.
Documentation shall consist of documents of significance for the implementation of the clinical trial and that provides a basis for evaluating the quality of the results of the trial.
Documentation shall include information on whether the investigator and the sponsor have complied with the rules of good clinical practice and the requirements set out in Appendix I to Directive 2001/83 / EC.
Documentation will form the basis for the audits undertaken by sponsor's quality assurance personnel and government.
Document The content should be consistent with the contents of the individual phase of the clinical trial.

§ 8-2. Sponsors and investigator record keeping sponsor and the investigator shall retain documents of significant importance for the clinical trial in at least fifteen years after the trial ended.
The documents mentioned in the first paragraph shall be retained longer than fifteen years, if this follows from other regulations or by agreement between the sponsor and the investigator.
The archiving of documents shall be made in such a way that the request can immediately be made available to the authorities.
Test-persons records must be kept for the maximum period permitted under Norwegian law.

§ 8-3. Responsible person and access to archive sponsor shall appoint individuals within its organization who will be responsible for archiving documents.
Only named individuals responsible for the archives should have access to it.

§ 8-4. Requirements for media document retention The media used for archiving documents, shall ensure

A)
that documents remain complete and legible throughout the period they should be stored

B)
that the documents requested could be made available to authorities

C)
that any change in the documents can be traced.

§ 8-5. Final report and final report Within 90 days after the clinical trial has ended sponsor undertakes to notify the Norwegian Medicines Agency and the Ethics Committee that the study is completed.
If the clinical trial must be interrupted, the sponsor shall notify the Norwegian Medicines Agency and the Ethics Committee within 15 days. It shall be given for why the trial was halted.
Latest one year after the trial is completed, the sponsor shall submit a final report to the Norwegian Medicines Agency. This time limit may be extended by the Norwegian Medicines Agency.

Chapter 9 - Entry into force etc.

§ 9-1. Commencement etc.. The regulations come into force immediately.
From the same date, the Regulations on 24 September 2003 no. 1202 relating to clinical trials of medicines for human use.