Study Start-up Process

The Regulatory Dossiers

 

Document

MoH

LEC

Language

Cover letter

v

v

G

Study sites and PIs

v

v

G, E

Insurance Certificate

v

v

G, E

Power of attorney provided by Sponsor to CRO

v

v

G, E

Study protocol and amendments

v

v

G, E

CRF

v

v

G, E

Pt information leaflets and ICF

v

v

G, E

Investigator brochure

v

v

E, G

Updated CVs of PIs

v

v

G

Updated CVs of Sub-Is

v

 

G

Medical license of study sites

v

 

G

Medical license of PIs

v

 

G

Valid GCP certificate of PIs

v

 

G

Excerpt of the applicant/representing registered company in Georgia (that’s us)

v

 

G

Fee payment confirmation (bank transfer)

v

 

G

LECs approvals

v

 

G

IMP labels

v

 

G, E

CD with electronic versions of the submission documents

v

 

G

 

All translated documents need to be notarized for the submission to MoH. MoH may also ask for GMP certificate/Certificate of Analysis of the study drug and for agreements with additional facilities (such as imagining institution or bacteriology lab) if used in the trial.
Insurance should be obtained from local insurer.

Agreements

Usually there are separate agreements for the institution and the investigator(s). There is no need to submit signed agreements to the MoH or LECs as part of the regulatory dossier, yet agreements should be signed before the actual initiation of the study.

Import/Export Permits

No export permit is needed for bio samples.
Import permit (custom clearance) is needed for IMPs, rescue and concomitant medications, pregnancy and microbiology tests. The license is granted for the whole duration of the study.
The application consists of:

  • Cover letter with information about the products imported
  • Pro-forma invoice with total quantities and manufacturer details

That’s it. Fast, Simple and Straight Forward.