Meda Pharmaceuticals USA

 INVESTIGATOR INITIATED STUDY REQUEST FORM
Instructions

This application is meant for IIS requests in Meda's areas of scientific interest.

Complete all required fields, then submit this application via the button below.

To avoid delays in the evaluation process, complete, accurate and detailed information is required. Applications with insufficient information will either be denied or will require resubmission.

You will receive an automatically generated submission confirmation via email within 24 hours containing your IIS Application Number. The IIS Review Committee will make a determination and will respond to you within eight weeks.


You may direct any questions to the Meda IIS Office at InvestigatorInitiatedStudies@meda.us.


ALL FIELDS IN BOLD ARE REQUIRED


MEDA Drug Name:
Investigator Name:
 
Address 1:
Address 2:
Phone Number:
Fax Number:
Email:

 
Select one of the following:
    Preclinical     Clinical     Invitro    

State your Hypothesis:
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
State the Clinical Importance of the Research:
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
Objective of Study: (please include the Endpoints for Evaluation):
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
Literature Review: (Pertinent literature of interest):
 
Patient population to be studied (if applicable):
 
Estimated number of patients: (if applicable):
 
Study Methodology:
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
Outcome Assessments:
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
Drug Quantity Requested (if applicable):
 
Anticipated Cost (if applicable):
(If attaching document at the end of this form, indicate 'See Attached' in this field)
 
 Representative Considerations:
Physician License - Do you have a current Physician license in the USA
    YES     NO

    If "NO", List other professional credentials:
 
Organizational Affiliations - List all applicable affiliations:
 
If this is a clinical trial:
(If not applicable, please select N/A on questions below)
 
Does the investigator have a recent (within the last 2 years) record of GCP training?
    YES     NO     N/A

    If "YES", state date:
 
Is the investigator adequately staffed to conduct all required reporting as applicable by GCP requirements (i.e. annual reports, SAEs..etc)
    YES     NO     N/A

    If "NO", please comment:
 
Do you have a protocol deviation SOP?
    YES     NO     N/A

    If "NO", please explain how will deviations be handled:
 
Do you have procedures to cover unanticipated problems posing risk to subjects?
    YES     NO     N/A

    If "NO", please comment:
 
Is IRB oversight needed for this trial?
    YES     NO     N/A

    If "NO", please comment:
 
 Expertise and Qualification of the Investigator
List of the Investigator's credentials and/or any other relevant training in the subject matter of the trial:
(Please attach a recent copy CV)
 
Number of centers - Is this a multi or single center study? If multiple, please list number of centers: :
 
Site Audit - Will the site be willing to host an audit by Meda if needed?
    YES     NO

    If "NO", please comment:
 
IND - Will this study require an IND?
Refer to Link below for details: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf
    YES     NO

    If "NO", please explain:
 
 Inspections:
Have you ever had an inspection? By a regulatory agency?
    YES     NO

    If "YES", Please attach a copy of the EIR at the bottom of this form.
 
Have you or any of your investigators been subject to investigation/debarment disciplinary proceedings?
    YES     NO

 
Conflict of Interest - Is the investigator/study/site funded by another commercial entity or organization which may have competing intellectual property rights?
    YES     NO

    If "YES", please explain:
 
Is the study or site funded by government funding? Is inv or sub inv a government employee or contractor?
    YES     NO

    If "YES", please explain:
 
 
You may attach one or more files to the application that includes any relevant supporting documentation. You may attach as many as eight (8) files. The following formats are accepted; .txt, .rtf, .doc, .docx, .xls, .xlsx, and .pdf.

 
 
 
 
 
 
 
 

 Please check this box to confirm that with completion of the form and submission you certify that the information provided is true, accurate and complete.



ALL FIELDS IN BOLD ARE REQUIRED