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hi every one
I have one doubt.
ie whether the investigator can act as a clinical pharmacologist
(suppose he is MD pharmacologist). I can put it in other word can
Investigator play dual role (as investigator & pharmacologist).
Otherwise apart from investigator (he is pharmacologist), should we
have one more pharmacologist (apart from the investigator)
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The following message was posted to: PharmPK
Dear Krish,
It is not a mandatory requirement that you have to have a clinical
pharmacologist as an Investigator. Any person from science background
(preferably a medical person) can be an Investigator and if he happens
to be a Clinical Pharmacologist, it will more beneficial, that's it.
Hope this information helps.
Regards,
Dr. M. Joseph MD
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The following message was posted to: PharmPK
Dear All,
In addition, Please refer to the link further information,
(Guidelines For
BA/BE studies in India).
www.cdsco.nic.in/html/BE%20Guidelines%20Draft%20Ver10%20March%2016,%
2005.pdf
Page 29 states -"The investigator should possess appropriate medical
qualifications and relevant experience for conducting pharmacokinetic
studies".
Hope this will be helpful to select an Investigator at the study site
(CRO).
As if the studies have to be conducted in India, then we should follow
Indian Regulatory Guidelines along with other agency guidelines where
the
submission is intended.
Thanks & regards,
Dr. Manoj Bose, MD
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dr. joseph,
thank you for the comment.
still i have got doubt.
1. As you have metioned --ANY PERSON HAVING SCIENCE BACKGROUND
(PREFERABLE MEDICAL PERSON) CAN BE INVESTIGATOR.
But as per the guidelines, they have mentioned MEDICAL PERSON
- THAT MEANS DOCTORS ONLY OR WHAT. But as per your statement --any
person having science back gournd - means whether apart from the
medical (mbbs)- para medics person can be a investigator like
nursing, pharmacy.
2. When you refer regarding guideline for the clinical trials ie
Schedule Y - In this schedule they have mentioned the eligibility
criteria for Investigator, refer MCI guidelines. But when you go
thru the MCI web site, they have not mentioned any thing.
So Once again confusion.
My main doubt which i have asked is, suppose if i am using clinical
pharmacologist as investigator, whether we need to have seperate
clinical pharmacologist is required for the study or not. Because
any one need to sign for authorisation for GCP.
Kindly clarify in this regard.
thank u
devisha.
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Dear Devisha,
This is a tricky issue, as it depends on individual's interpretation
of GCP. Because GCP (sec 4.1) and schedule Y (Sec 2.0) does not
specify that only a medical person has to be the Investigator, as
they have the provision of having a physician or dentist as a co
investigator who has to take care of the safety issues. But now, it
has become a universal norm, that only a medical person is appointed
as an Investigator. So if your IEC and sponsor agrees for a non
medical person as Principal Investigator and separate medical person
as a con-investigator, then that will be fine (I suppose).
And regarding your second query, it is not mandatory that should have
a Clinical Pharmacologist (CP) as the investigator/signing authority
for a study. Having a CP will be ideal, considering his Pharmacology
background, that's all.
Hope this will clarify.
Views from other members are welcome.
Regards,
Dr. M. Joseph MD
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dr. joseph,
thank you for your comment.
I have attached herewith the extracts from GCP - schedule Y of CDSCO
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.
and also given the following statements.
3.3.2. Medical care of the study subjects
A qualified Medical Practitioner (or a Dentist, when
appropriate) who is an Investigator or a Co-Investigator for the
study should be responsible for all study related medical
decisions. Investigator has to ensure that adequate medical care is
provided to a subject for any adverse events including clinically
significant laboratory values related to the study. Investigator
should inform the subject when medical care is needed for inter-
current illness(es) of which the investigator becomes aware.
Investigator should also inform the subject's other attending
physician(s) about the subject's participation in the study if the
subject has another attending physician(s) and if the subject agrees
to such other physician(s). Subsequent to the completion of the
study or dropping out of the subject(s) the investigator should
ensure that medical care and relevant follow-up procedures are
maintained as needed by the medical condition of the subject and the
study and the interventions made.
Although a subject is not obliged to give reason(s) for
withdrawing prematurely from a study, the investigator should make a
reasonable effort to ascertain the reason(s) while fully respecting
the subject's rights.
and kindly refer guidelines for BA BE studies in CDSCO:
they are given the following
6.3 organisation and management:
The study site organisation must include the following:
a. An investigator who has the overall responsibility to provide of
the human subjects. The investigator should possess appropriate
medical qualifications and relevant experience for conducting
pharmacokinetic studies.
b. The site should have identified adequately qualified and trained
personnel to perform the folliwng functions.
Pharmacology unit
analytical lab
data handling and interpretatin
documentation
QA
like wise the guidelines goes on..
So if you dont mind once again confusion.
To be investigator is it medical person is required or not. if
suppose the investigator paramedics (like nursing, pharmacy) and
having experiences in BE studies is it ok.
kindly give your comments.
devisha.
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dr. bose
In the guidelines they have not given clear picture of what is mean
by medical qualifications.
as per dr. joseph mail, investigator may be medical qualification or
any person having science background likewise also they have mentioned.
if you go thru my other mail i have given the extract of guidelines.
so that is the confusion.
if you have any idea kindly give.
devisha.
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Dear Devisha,
If clinical pharmacologist is investigator, he can provide (conduct)
GCP / Protocol training as well as sign study related forms.
In the other words a clinical pharmacologist can act as an
investigator as well as a physician performing screening, checking
vitals, attending Adverse event etc.
As it may be difficult for a clinical pharmacologist to perform so
many activities, it is advisable to take help of a co-investigator.
Hope this helps.
Any comments or suggestions regarding this matter is appreciated.
Regards,
Sumanta
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Dear all
I have a question regarding this matter, we don't have a principal
investigator but we have a clinical investigator (MD) who is
responsible for
almost every issue, would that suffice from a regulatory point of
view? Do
we need a principal investigator? All issues related to the clinical
conduct
are handled by coordinating staff except of course for issues related to
subjects. What I am trying to say it is not how you present the
titles, it
is more of having the right qualified staff for the positions in
question
and that the conduct of clinical studies is carried by medical staff
with a
physician or an equivalent qualified individual with a medical
background in
charge.
Raja Sammour
QA Supervisor
Triumpharma
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Devisha,
First, I would like to clarify that the excerpts what you have sent
is of our Indian GCP (by ICMR) and not from schedule Y, because
schedule Y (sec 2.0, subsec.ii) did not specify about a medical
person being the Principal Investigator (PI) like the ICH GCP. And
like any other issue, still our government is not clear about the
clinical trial guidelines; as the sec 3.3.1 and 3.3.2, you have sent
is not clear about who should be the PI. But our CDSCO guidelines for
BA/BE clearly states that only a medical person can be the PI.
So, as I have mentioned earlier, it all depends on how you interpret.
If you are determined to have a non medical person as your PI and a
medical person as a Co-Investigator, then you should be well prepared
to convince your IEC and sponsor (which I suppose would be a tough
task).
My suggestion will be, better to have a medical person as the PI,
which will save you lot of time and embarrassment (in any case you
will be having a medical person in your study).
Hope I have given some useful information this time,
Regards,
Dr. M. Joseph MD
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The following message was posted to: PharmPK
Dr. Joseph
I have one more question on this. is it necessary that Prinicipal
Investigator for BA/BE study should be MD. Can MBBS doctor who has
experience in BA/BE suffice.
Does any agency recommend for specific qualification of Prinicipal
Investigator?
Regards
Dr Ashish Mungantiwar
Head-Bioequivalence and General Manager Medical Services
Macleods Pharmaceutical Limited, India
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The following message was posted to: PharmPK
Dear Dr. Ashish,
It is not necessary. Any medically qualified person (MBBS also) with
sufficient experience can be the principal investigator.
As regard to your second question, there is no mention of any specific
qualification of the principal investigator in most of the existing
guidelines. It is also dependent upon the law of the country where the
study is being conducted. As mentioned in the WHO draft guidelines for
CROs conducting BE studies...
"... The investigator(s) should have appropriate qualifications, be
legally allowed to practice medicine, be suitably trained and have
experience in the conduct of the bioequivalence studies (the legal
status of persons authorized to act as investigators may differ between
countries)."
As regards to conducting BE studies in India, schedule Y provides..
"... All trial Investigator(s) should possess appropriate
qualifications, training and experience.. A qualified physician (or
dentist, when
appropriate) who is an investigator or a sub-investigator for the trial,
should be responsible for all trial-related medical (or dental)
decisions..."
CDSCO (India) also asks for..
" ....Education,training & experience that qualify the Investigator for
the clinical trial (Attach details including Medical Council
registration
number, and / or any other statement(s) of qualification(s))"
GCP says
" The investigator(s) should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the trial,
should meet all the qualifications specified by the applicable
regulatory requirement(s), and should provide evidence of such
qualifications through up-to-date curriculum vitae and/or other relevant
documentation requested by the sponsor, the IRB/IEC, and/or the
regulatory authority(ies).... A qualified physician (or dentist, when
appropriate), who is an investigator or a sub-investigator for the
trial, should be responsible for all trial-related medical (or dental)
decisions."
I guess a suitably experienced MBBS personnel may be the principal
investigator for BE studies.
Suggestions in this regard from other researchers will be highly
appreciated.
with best regards,
Dr. Kshitij Soni
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The following message was posted to: PharmPK
Dear Dr. Ashish,
It is not necessary. Any medically qualified person (MBBS also) with
sufficient experience can be the principal investigator.
As regard to your second question, there is no mention of any specific
qualification of the principal investigator in most of the existing
guidelines. It is also dependent upon the law of the country where the
study is being conducted. As mentioned in the WHO draft guidelines for
CROs conducting BE studies...
"... The investigator(s) should have appropriate qualifications, be
legally allowed to practice medicine, be suitably trained and have
experience in the conduct of the bioequivalence studies (the legal
status of persons authorized to act as investigators may differ between
countries)."
As regards to conducting BE studies in India, schedule Y provides..
"... All trial Investigator(s) should possess appropriate
qualifications, training and experience.. A qualified physician (or
dentist, when
appropriate) who is an investigator or a sub-investigator for the trial,
should be responsible for all trial-related medical (or dental)
decisions..."
CDSCO (India) also asks for..
" ....Education,training & experience that qualify the Investigator for
the clinical trial (Attach details including Medical Council
registration
number, and / or any other statement(s) of qualification(s))"
GCP says
" The investigator(s) should be qualified by education, training, and
experience to assume responsibility for the proper conduct of the trial,
should meet all the qualifications specified by the applicable
regulatory requirement(s), and should provide evidence of such
qualifications through up-to-date curriculum vitae and/or other relevant
documentation requested by the sponsor, the IRB/IEC, and/or the
regulatory authority(ies).... A qualified physician (or dentist, when
appropriate), who is an investigator or a sub-investigator for the
trial, should be responsible for all trial-related medical (or dental)
decisions."
I guess a suitably experienced MBBS personnel may be the principal
investigator for BE studies.
Suggestions in this regard from other researchers will be highly
appreciated.
with best regards,
Dr. Kshitij Soni
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The following message was posted to: PharmPK
Dr Ashish,
Since no guidelines has specified about the qualifications of an
Investigator, I believe having an MBBS doctor with enough experience and
training to conduct and manage clinical studies (as specified in GCP),
would not be an issue.
Regards,
Joseph
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dr. ashish,
No indian guidelines have given the details. They have mentioned
medical person only with experience of conducting BABE studies.
But MD is better - the reason is qualification wise it is superior
and moreover they will have more knowledge about the medicine etc.,
devisha.
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hi soni,
this is what we are discussing for the past 3 to 4 days.
I think you forget to see other points in guidelines for ba/be
studies which released by the drug department.
there they have investigator must be medical person. if you see the
meaning for medical person then it is nothing but a doctor.
may be mbbs or md no problem. better md what i feel.
devishabana
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The following message was posted to: PharmPK
There appears to be a misconception that the principal investigator
needs to be a medical doctor. In the US, this is not the case and
any investigator can qualify based on education, training and
experience. However, these needs to be one medical doctor as an
investigator in studies with human subjects but that individual may
be a sub investigator and not necessarily the principal
investigator. In many PK studies, the medical doctor plays a minor
role and may be on a contract to provide medical coverage for the
study. If the study was investigating medical or surgical treatment,
obviously that would require the PI be a medical doctor or surgeon.
Cordially,
Will
William Webster, PharmD, FCCP, BCPS
Office: 727-363-0072
Fax: 908-259-2338
9525 Blind Pass Rd
Courageous 1001
St Pete Beach, FL 33706
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The following message was posted to: PharmPK
I would agree with the comments by Dr. Webster. There are many PharmD
and PhD investigators around the Country who own, run and/or managed
clinical trials units and serve as the principal investigator on human
phase trials (Phase I-IV). I would clarify that a PharmD or PhD could
serve as the PI even on a medical treatment trial as we have for many
years. The PI is serving as a protocol "director" as an analogy and the
bank of sub investigators would logically include coverage for all of
the diversity of clinical activities involved with the trial.
It is important for a PI to ensure that all diagnostic and
interventional needs are meet for the respective trial design. This in
no way implies that a "Principal Investigator" must be an expert in
"every" need or service within any given trial. Rather it implies that
the PI should assemble the best skilled team within their practice or
community to perform the trial activities to the highest level of
quality. The PI role assumes the responsible for the trial processes,
quality and compliance.
Dan
Daniel E. Buffington, PharmD, MBA
Clinical Pharmacology Services
6285 E. Fowler Ave
Tampa, FL 33617
813-983-1500 Office
813-983-1501 Fax
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The following message was posted to: PharmPK
A PharmD or other suitably qualified person can certainly be a principle
investigator. However, at least 1 physician should be a sub-
investigator,
because a licensed physician is recognized as able to diagnose. That
is the
critical factor, diagnosis. Whether evaluating laboratory values,
assessing
EKGs and/or other screening activities, assignment of AE severity,
etc, the
ability to diagnose and/or treat patients or subjects is important and
necessary for optimum safety.
Gregory M Hicks, PharmD, BCPS
Clinical Research Manager,
Roxane Laboratories, Inc
614-241-4106
ghicks.at.col.boehringer-ingelheim.com
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dr. webster,
Indian Guidelines are extracted from the fda guidelines. Indian FDA
says, follow the guidelines of MCI (medical Council of India) -
regarding the Eligibility criteria for Investigator.
In US, Pharmacist plays role in prescription. But in India it is
not like that. So In india the condition is different what i feel.
If fda referes MCI, then whatever MCI says we have to follow.
this is the situation.
devisha.
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