joy_fm
☆    

Indonesia,
2014-10-27 04:20
(3440 d 07:51 ago)

Posting: # 13805
Views: 9,905
 

 Subject Recruit­ment [Off Topic]

Dear all,

I would be grateful if you could provide me with some feedback regarding subject recruitment.
To prevent delays in conducting BE studies because of the difficulty in obtaining subject candidates,
Is it allowed to create 2 type of protocol and informed consent, as follows:
The first protocol (and informed concent) is made for subject recruitment of general BE studies, without specific information of investigational drugs mentioned in protocol.
Second protocol (and informed concent) is made for specific BE studies.
The main purpose of the first protocol (and informed concent) is to obtain subject pool. So when FDA approval of second protocol (and informed concent) has been obtained, we don't need to rush to get subject candidates, because we already have subject pool.

Thank you

Best regards
Joy_fm
ElMaestro
★★★

Denmark,
2014-10-27 10:37
(3440 d 01:33 ago)

@ joy_fm
Posting: # 13806
Views: 8,700
 

 Subject Recruitment

Hi joy_fm,

❝ Is it allowed to create 2 type of protocol and informed consent, as follows:

❝ The first protocol (and informed concent) is made for subject recruitment of general BE studies, without specific information of investigational drugs mentioned in protocol.

❝ Second protocol (and informed concent) is made for specific BE studies.

❝ The main purpose of the first protocol (and informed concent) is to obtain subject pool. So when FDA approval of second protocol (and informed concent) has been obtained, we don't need to rush to get subject candidates, because we already have subject pool.


You do not need a protocol in order to create a subject database as long as this is just a list of subjects who has an interest in participating in studies. Once you start testing them you need the protocol though to deem them fit or not. Thus the answer depends on what you mean with "subject recruitment of general BE studies".

Pass or fail!
ElMaestro
priya
☆    

India,
2014-10-27 13:23
(3439 d 22:47 ago)

@ joy_fm
Posting: # 13807
Views: 8,649
 

 Subject Recruitment

Hi Joy,

❝ The first protocol (and informed concent) is made for subject recruitment of general BE studies, without specific information of investigational drugs mentioned in protocol.

❝ Second protocol (and informed concent) is made for specific BE studies.


Usually, as per CRO's SOP on "General Screening of Volunteers and Registration in Volunteer Databank", volunteers will be registered and screened well in advance to the study period to have sufficient number of eligible volunteers in the CRO's volunteer databank. Volunteer registration and screening will be done after they signed in Informed Consent Form for Registration and General Screening. There is no need to have separate protocol for Volunteer's Registration and General Screening. However, the SOP and Informed Consent Document on Volunteer's Registration and General Screening should be approved by Independent Ethics Committee before implementation. Based on the fit volunteers pool in the volunteer databank, you can select volunteers and informed consent specific for a particular study will be provided to the selected volunteers and you can conduct the study without any time delay.

Priya.
Dr_Dan
★★  

Germany,
2014-10-27 13:47
(3439 d 22:23 ago)

@ joy_fm
Posting: # 13808
Views: 8,746
 

 Subject Recruitment

Dear Joy_fm
Your procedure is acceptable as long as you ensure that not only the study specific documents but also the general ICF is approved by the ethics committee.
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
joy_fm
☆    

Indonesia,
2014-10-28 04:24
(3439 d 07:47 ago)

@ Dr_Dan
Posting: # 13809
Views: 8,622
 

 Subject Recruitment

Dear ElMaestro, Priya, and Dr_Dan,

Thank you for your feedbacks. Your feedbacks are important for me.

@ElMaestro : "subject recruitment of general BE studies" means subject candidates who already signed ICF of general BE Study, directly following physical and laboratory examinations, without waiting FDA approval for the second protocol and informed consent of specific BE Studies.

@Priya : I absolutely agree with you. But I think it will be better if we have "general protocol of BE Study" rather than "SOP".

@Dr_Dan : Yes, both protocols and informed consents should get approval from Ethic Committee. But how about FDA approval ? Whether both protocols and informed consents (general BE Study and specific BE Studies) should be approved by FDA ? Or FDA only need to approve protocol and informed consent of specific BE Studies ? And if you don’t mind, could you explain the reason.

I’m sorry for asking so many questions,,,
thank you

Best regards
joy_fm
priya
☆    

India,
2014-10-28 15:29
(3438 d 20:41 ago)

@ joy_fm
Posting: # 13811
Views: 8,525
 

 Subject Recruitment

Hi Joy,

❝ @Priya : I absolutely agree with you. But I think it will be better if we have "general protocol of BE Study" rather than "SOP".

You can have General Protocol of BE study rather than SOP also. Whether SOP or General Protocol of BE study, both should be approved by Ethics Committee before implementation.


❝ @Dr_Dan : Yes, both protocols and informed consents should get approval from Ethic Committee. But how about FDA approval ? Whether both protocols and informed consents (general BE Study and specific BE Studies) should be approved by FDA ? Or FDA only need to approve protocol and informed consent of specific BE Studies ? And if you don’t mind, could you explain the reason.


Usually, Sponsors will not submit either General Protocol or Study Specific Protocol & Informed Consent Documents to FDA before study initiation. As per Recent FDA's Draft Guidance on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA, only if you are wishing to use variations of FDA recommended study designs or analysis methods (e.g., a sequential design or scaled-average BE), then you need to submit the protocol to FDA for review and their comment before initiation of the study.
For some molecules such as Isotretinoin, FDA request to submit both the protocol and informed consent document to them for their review and approval before initiation of the study.
Hence, for other molecules, no need to submit the protocol and consent document to FDA for their review and approval.

Priya.
joy_fm
☆    

Indonesia,
2014-10-29 10:57
(3438 d 01:13 ago)

@ priya
Posting: # 13813
Views: 8,471
 

 Subject Recruitment

Dear Priya,

thank you for answering my questions.

I would like to clarify the meaning of 'FDA' in my previous email is local FDA, not US FDA.

Thank you
joy_fm
priya
☆    

India,
2014-11-03 10:52
(3433 d 01:18 ago)

@ joy_fm
Posting: # 13825
Views: 7,974
 

 Subject Recruitment

Hi Joy,

❝ I would like to clarify the meaning of 'FDA' in my previous email is local FDA, not US FDA.


I am not sure about submitting the Protocol and ICD to local Indonesian FDA before study initiation.
Please have a look into Indonesian BE regulations in the below link
http://www.pom.go.id/index.php/home/en

Priya.
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,639 registered users;
94 visitors (1 registered, 93 guests [including 9 identified bots]).
Forum time: 12:11 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5