Ghana - Apply for Clinical Trial Authorisation and Monitoring

Advertisement

Procedure

Apply In-Person:

1. To Apply for Clinical Trial Authorisation and Monitoring in person, the applicant has to approach the Food and Drugs Authority (FDA) office.
2. Address and contact details can be found in the following Contact link
3. Applicants obtain the application form for Apply for Clinical Trial Authorisation and Monitoring.
4. Read carefully through the application forms as there contain different section.
5. All clinical trial application documents shall be submitted in hard and soft copies (1 each; format of soft copy of documents submitted should be in searchable PDF).
6. The applicant should make sure are eligible for apply for clinical trial authorisation and monitoring by reading through the eligibility criteria that has been listed out under the “Eligibility” of this page.
7. Documents that are needed for this procedure are mentioned under “Required Documents” section of this page.
8. Please complete each section of this application form as a Word document then submit printed version of the completed form along with the copies of the supporting documents (listed below) to the FDA regional and district office or the head office.
9. Payment of appropriate fees should be made and that can be found under the "Fees" section of this page.
10. Pay the processing fees, upon which you will be issued with a receipt.
11. A CTD investigating panel/committee will be formed to investigate, if the clinical trials of benefit to the general public and that it will not harm them in any way and write a report on their finding.
12. The applicant may be summoned for an interview by the CTD investigation panel.
13. If the authorized official is satisfied with the report issued by the panel, stating that the product/drug Safety, quality and efficacy of the product/drug comply with conditions of registration, you will be notified of the approval and issued with the certificate.
14. The processing time for this procedure takes 1 to 2 months.

Note:

• A Clinical Trial Application shall be rejected if upon preliminary assessment at the time of submission, less than 70% of the required documents as per Section 3.1 are available. This 70% shall include the application fee, a duly signed protocol, IB, completed FDA application form and application fee.
• Failure of applicant to address all outstanding issues related to an application within a year renders an application null and void.

Advertisement

Required Documents

• Covering Letter
• A non-refundable Application Fee as per the prescribed Fee Schedule.
• Completed Food and Drugs Authority Application Forms for Conducting Clinical Trials signed by authorized persons (PI and Sponsor’s authorized representative)
• A Clinical Trial Protocol
• A proof of registration with Pan African Clinical Trials Registry (PACTR)
• Investigator’s Brochure (IB)
• Investigational Product (IP) Dossier
• Good Manufacturing Practice (GMP) Certificate
• Ethics Committee (EC)/Institutional Review Board (IRB) Approval (at least evidence of submission of application to EC/IRB if final approval is not yet available)
• Insurance Cover for all study participants
• Financial Declaration
• DSMB Membership and signed Charter
• Sponsor/PI Contractual Agreement
• Informed Consent and Assent Forms (if applicable)
• Statistical Analysis Plan (SAP)
• Materials Transfer Agreement (if applicable)

Office Locations & Contacts

Cover Letter Addressed To:
The Chief Executive, Food and Drugs Authority
P.O. Box CT 2783, Cantonments – Accra GHANA.

Return Completed Form To:
Chief Executive Officer, Food and Drugs Authority,
17 South Legon Commercial Areas, SHIASHIE, ACCRA.
Contact link

Location: Accra
Address: Food and Drugs Authority
Health consultant in Accra, Ghana. 17 Nelson Mandela Ave, Accra, Ghana.
JRG9+2Q Accra, Ghana
Contact number- +233 30 223 3200
Location link

Eligibility

• Companies/organization must have registered in FDA.
• Must be qualified by education, training and experience.
• Excellent knowledge in local regulatory requirements.
• Must have evidence of Good Clinical Practice training organized by The Authority within the last 2 years.
• Must be resident in Ghana.

Fees

An application shall be accompanied by a non-refundable application fee as specified in the Food and Drugs Authority Fee Schedule. Please see the fees on our website Link

Validity

Explain the time until which the certificate/document is valid.
e.g. Birth Certificate Valid Forever

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

• The processing time for this procedure takes 1 to 2 months.

Related Videos

Videos explaining the procedure or to fill the applications.
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites.
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver,
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.gIn the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• In pursuance of the Public Health Act, 2012, Act 851, Part 8, 150-166, these Guidelines are hereby made by the Food and Drugs Authority, hereafter referred to as The Authority, to define the general norms and scientific principles and to set applicable standards for the conduct, performance and control of clinical trials in humans in Ghana.

Required Information

1.General Information
This shall include:

• Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).
• Name and address of the Sponsor and monitor (if other than the Sponsor)
• Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the Sponsor.
• Name, title, address, and telephone number(s) of the Sponsor's medical expert (or dentist when appropriate) for the trial.
• Name and title of the Principal Investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).
• Name, title, address, and telephone number(s) of the other investigators designated by the PI to be responsible for some aspects of the study.
• Name(s) and address (es) of the clinical laboratory (ies) and other medical and/or technical department(s) and/or institutions involved in the trial.
• Contractual agreement between the investigator and Sponsor.
• A clear statement on compensation and benefits package for clinical trial participants.
• Publication policy
• Contractual agreement between the investigator and Sponsor.
• A clear statement on compensation and benefits package for clinical trial participants.
• Publication policy

2.Background Information
This shall include:

• Name and description of the investigational product(s).
• A summary of findings from nonclinical studies that potentially have significance to the clinical trial
• Summary of findings from clinical studies/trials that are relevant to the trial.
• Summary of the known and potential risks and benefits, if any, to human participants.
• Summary of the local background rates with respect to the condition for which the intervention is proposed.
• Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).
• Description of the population to be studied.
• A statement that the trial shall be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
• References to literature and data that are relevant to the trial and that provide background for the trial.
• Signed declaration by the applicant and all investigators that they are familiar with and understand the protocol and shall comply with principles of Good Clinical Practice (GCP) as determined by the Food and Drugs Authority in the conduct of the trial.
• Justification for the trial is being conducted in Ghana.

3.Trial Purpose and Objectives

• Aim of the trial and reason for its execution.
• A detailed description of the objectives and the purpose of the trial.

4.Trial Design

• A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.
• If markers are being used as endpoints, they should be validated.
• A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.
• Number of participants to be involved in the trial and the statistical justification.
• A description of the measures taken to minimize/avoid bias, including: Randomization and Blinding.
• A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s).
• Description of the dosage form packaging, and labeling of the investigational product(s) and sample of label to be used for investigational product.
• The expected duration of participant participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.
• Quantities and sources of all investigational medicines and/or comparators (whether to be imported or purchased locally).
• A detailed description of the "stopping rules" or "discontinuation criteria" for individual participants, parts of trial and entire trial.
• Accountability procedures for the investigational product(s).
• Maintenance of trial treatment randomization codes and procedures for breaking codes.
• The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.
• Specifications and instructions for anticipated deviations from the protocol.

5.Selection and withdrawal of participants

• Participant inclusion criteria.
• Participant exclusion criteria.
• Participant withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:
• When and how to withdraw participants from the trial/investigational product treatment.
• The type and timing of the data to be collected for withdrawn participants.
• Whether and how participants are to be replaced.
• The follow-up for participants withdrawn from investigational product treatment/trial treatment.

6.Treatment of Participants

• The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for participants for each investigational product treatment/trial treatment group/arm of the trial.
• Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.
• Procedures for monitoring participant compliance.
• Description of treatment applied to control group(s) or control period(s), placebo, and other therapy and any other treatment that may be given concomitantly including measures to be implemented to ensure the safe handling of the products.
• Description of diagnostic devices or kits applied to be used in the clinical trial.
• Description of special analyses and/or tests or procedure to be carried out.

7.Assessment of Efficacy

• Specification of the efficacy parameters.
• Methods and timing for assessing, recording, and analyzing of efficacy parameters.
• Clear procedures for interim assessment of trial.

8.Assessment of Safety

• Specification of safety parameters.
• The methods and timing for assessing, recording, and analyzing safety parameters.
• Procedures for eliciting reports of and for recording and reporting adverse event and undercurrent illnesses.
• List of adverse events of special interest (AESI) and/or expected adverse events – information shall include:
  • Whether event is related to the intervention or not.
  • Rationale for listing each event
  • Expected rate or frequency of each event
  • Laboratory limits (if applicable)
• The type and duration of the follow-up of participants after adverse events.
• Provision for dealing with all adverse events. Copy of form to be used to report adverse event

9.Name and address of the applicant

• Name
• Company name
• Address
• Country
• Telephone
• Telefax
• E-mail
• Declaration

Need for the Document

• Clinical Trial Authorization means any issued or pending Permit required to be obtained from, as applicable, a Governmental Authority or IRB, in order to conduct a Clinical Trial under applicable Law, including, an IND.

Information which might help

Clinical trials shall be categorized as follows:

• Trials directed by The Authority.
  
• Trials initiated by pharmaceutical companies or agencies.
  
• Trials initiated by academic and research institutions either locally or as part of an international multi-centre study.
  

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Link

Others

More information which might help people.