isra_amm
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2006-04-29 16:38
(6543 d 22:42 ago)

Posting: # 96
Views: 10,385
 

 qualification of Principal Investigator [Regulatives / Guidelines]

Good morning.
I have a question regarding the qualifcation of the Principal Investigator in BE and PK studies. Is is a prerequisite that the Principal Investigator must be a physician or Ph.D holder for studies submitted to Europe and FDA ?
Is there a reference that I can refer to regarding this issue?

Thanks in advance and best regards
Isra'
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2006-05-02 19:21
(6540 d 19:59 ago)

@ isra_amm
Posting: # 101
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 Qualification of Principal Investigator (Germany, Austria)

Hello Isra'!

❝ Is is a prerequisite that the Principal Investigator must be a physician or Ph.D holder for studies submitted to Europe and FDA?


Some informations concerning European rules:
The European legislation was harmonized with directive 2001/20/EC, but still differ in the member states. You should contact a consultant and/or lawyer of the respective European member state for further informations.

Just to give you two examples:

1. Germany
Medicines Act ('Arzneimittelgesetz' 2005)
§4 (25)
Prüfer ist in der Regel ein für die Durchführung der klinischen Prüfung bei Menschen in einer Prüfstelle verantwortlicher Arzt oder in begründeten Ausnahmefällen eine andere Person, deren Beruf auf Grund seiner wissenschaftlichen Anforderungen und der seine Ausübung voraussetzenden Erfahrungen in der Patientenbetreuung für die Durchführung von Forschungen am Menschen qualifiziert.
§40 (1)
[…] Die klinische Prüfung eines Arzneimittels darf bei Menschen nur durchgeführt werden, wenn und solange
(5) sie in einer geeigneten Einrichtung von einem angemessen qualifizierten Prüfer verantwortlich durchgeführt wird und die Leitung von einem Prüfer, Hauptprüfer oder Leiter der klinischen Prüfung wahrgenommen wird, der eine mindestens zweijährige Erfahrung in der klinischen Prüfung von Arzneimitteln nachweisen kann […]

GCP-decree ('CGP-Verordnung' 2006)
§7 (2) Dem Antrag an die zuständige Ethik-Kommission und dem Antrag an die zuständige Bundesoberbehörde müssen vom Antragsteller die folgenden Angaben und Unterlagen beigefügt werden:
6. Angabe der Berufe von Prüfern, die nicht Arzt sind, der wissenschaftlichen Anforderungen des jeweiligen Berufs und der seine Ausübung voraussetzenden Erfahrungen in der Patientenbetreuung sowie Darlegung, dass der jeweilige Beruf für die Durchführung von Forschungen am Menschen qualifiziert und Darlegung der besonderen Gegebenheiten der klinischen Prüfung, die die Prüfertätigkeit eines Angehörigen des jeweiligen Berufs rechtfertigen […]

My personal translation - I am not a translator ;-)
§4 (25) The investigator is generally a physician responsible for the conduct of the clinical trial on human beings at a site or, in justified exceptional cases, another person whose profession, owing to the scientific requirements and the experience in the care of patients which it calls for, qualifies him to conduct research on human beings.
§40 (1) […] The clinical study of a medicinal product in humans may only be conducted if and as long as
(5) it is conducted in an appropriate facility by a suitably qualified investigator in a responsible manner and its management is assumed by an investigator, principal investigator or chief investigator who can provide evidence of at least two years' experience in the clinical trial of medicinal products.
§7 (2) The applicant must append the following information and documentation to the application to the responsible ethics committee and to the application to the responsible Federal Authority:
6. Declaration of occupations of investigators who are no physicians, scientific qualification of the respective occupation and its excercise requiring experiences in the medical care of patients, as well as demonstration of the specific circumstances of the clinical study, which justifies the investigator's function of a member of the respective occupation […]
2. Austria
Medicines Act ('Arzneimittelgesetz' 2005)
§35 (1) Prüfer darf nur ein Arzt oder Zahnarzt sein, der zur selbständigen Ausübung seines Berufes in Österreich berechtigt ist, und
1. über entsprechende Kenntnisse und Erfahrungen auf dem Gebiet der klinischen Prüfung von Arzneimitteln verfügt,
2. über entsprechende Kenntnisse und Erfahrungen auf dem vorgesehenen Indikationsgebiet und
3. über Kenntnisse auf den einschlägigen Gebieten der nichtklinischen Medizin, insbesondere auch über Biometrie, verfügt.
(2) Der Nachweis über die genannten Eignungskriterien ist seitens des Prüfers dem Bundesministerium für Gesundheit, Sport und Konsumentenschutz sowie dem Sponsor zu erbringen. Falls der Prüfer auf einem der Teilgebiete gemäß Abs. 1 Z 3 nicht die entsprechenden Kenntnisse und Erfahrungen besitzt, sind von ihm einschlägige Fachkräfte mitverantwortlich beizuziehen.

My translation:
§35 (1) The investigator must solely be a physician or dental surgeon, who is legally qualified for indepent practice of occupation ('ius practicandi') in Austria, and has
1. adequate proficiency and experiences in the area of clinical studies of medicinal products,
2. adequate proficiency and experiences in the intended indication, and
3. proficiency in the relevant areas of nonclinical medicine, particularly biostatistics.
(2) Evidence of the mentioned acceptability criteria must be produced by the investigator to the Ministry of Health, Sports and Consumer’s Care as well as to the sponsor. If the investiagtor is lacking proficiency and experiences in one of the partial areas mentioned in §35(1)3 appropriate specialists must jointly responsible be included.

❝ Is there a reference that I can refer to regarding this issue?


German Medicines Act (435 kB PDF)
GCP-decree (62kB PDF)
Austrian Medicines Act (885kB PDF)

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Helmut
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2006-07-21 22:34
(6460 d 16:45 ago)

@ isra_amm
Posting: # 186
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 qualification of PI (USA)

Hello Isra',

here you may find US-FDA's form #1572 'Statement of Investigator' in PDF-format.

You have two options...
2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR
   AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE DRUG FOR THE USE
   UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED.

       ☐ Curriculum vitae   ☐ Other Statement of Qualifications


FDA's Help Page does not give examples what 'qualification' actually means... ;-)

Concerning your question (MD, PhD,... and responsibilities) have a look at this message at FDA's GCP board.

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Dr.Pravin
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Ahmedabad,
2006-11-23 13:45
(6336 d 00:34 ago)

@ isra_amm
Posting: # 372
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 Responsibility of Principal Investigator in BA/BE Study

Hi, thanks for your Reply for the Previous messeges,

Plese Specify the Responsibility of Principal Ivestigator for BA/BE Study.

Thanks

Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad
Helmut
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2006-11-23 14:07
(6336 d 00:13 ago)

@ Dr.Pravin
Posting: # 373
Views: 8,480
 

 Responsibility of PI in BA/BE Study

Dear Dr.Pravin!

❝ Plese Specify the Responsibility of Principal Ivestigator for BA/BE Study.


Since a BA/BE study is just a special type of clinical study, qualifications and responsibilities already mentioned apply (for details you have to consult local laws).

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Dr.Pravin
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Ahmedabad,
2006-11-27 12:28
(6332 d 01:52 ago)

@ Helmut
Posting: # 374
Views: 8,504
 

 Responsibility of PI in BA/BE Study

Dear HS
its right, but ok.

give me detail idea about the Responsibility for PI in India. like conduct of BA/Be trials,

Dr.Pravin Ahir
Co-Investigator,
Accutest Research Pvt.Lab.(I), Ltd.
Ahmedabad
Helmut
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2006-11-27 14:16
(6332 d 00:04 ago)

@ Dr.Pravin
Posting: # 375
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 Responsibility of PI in BA/BE Study

Dear Dr. Pravin!

❝ give me detail idea about the Responsibility for PI in India. like conduct of BA/Be trials,


CDSCO's Guideline states at
6.3 Organisation and management:
The study site organization must include the following:
a. An Investigator who has the overall responsibility to provide of the human subjects. The Investigator(s) should possess appropriate medical qualifications and relevant experience for conducting pharmacokinetic studies.

I don't feel competent enough to explain what 'appropriate medical qualifications and relevant experience' are; but since according to my server-logs our colleagues from India represent the largest group of participants of the BE/BE-Forum within the last month (19% of all accesses), someone else should fill in this gap! ;-)

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2006-12-08 23:05
(6320 d 15:15 ago)

@ Helmut
Posting: # 389
Views: 8,513
 

 PI in India

Dear Dr. Pravin!

❝ give me detail idea about the Responsibility for PI in India. like conduct of BA/Be trials,


Indian GCP Regulations:

3.3. Investigator
3.3.1. Qualifications


The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI). The investigator should provide a copy of the curriculum vitae and / or other relevant documents requested by the sponsor, the ethics committee, the CRO or the regulatory authorities. He / she should clearly understand the time and other resource demands the study is likely to make and ensure they can be made available throughout the duration of the study. The investigator should also ensure that other studies do not divert essential subjects or facilities away from the study at hand.

The investigator should be thoroughly familiar with the safety, efficacy and appropriate use of the investigational product as described in the protocol, investigator's brochure and other information sources provided by the sponsor from time to time.

The investigator should be aware of and comply with GCPs, SOPs and the applicable regulatory requirements.

Thanks Kshitij for bringing this regulation to my attention!

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