Tanzania - Obtain Clinical Trials Letter of Approval

Advertisement

Procedure

Apply In-Person:

1. For Obtaining clinical trials letter of approval, the applicant has to visit the Ministry of Health contact link
2. Applicant must obtain the application form from the office and fill it up with all the necessary information in it.
3. Applicant should make sure to carry all documents (both photocopies and originals) of all documents that are needed for completing this procedure.
4. Documents that are needed for completing this procedure are mentioned under “Required Documents” section of this page.
5. Applicant should attach both photocopies and originals of all documents (whichever is necessary) along with the application form before submitting it at the office.
6. Fee for this procedure has to be paid as per the authority’s request.
7. If all these procedures were followed properly by the applicant, the license will be provided within a stipulated period of time.
8. If there is no information regarding the license is provided, the applicant can visit the office to know status of the application.

Advertisement

Required Documents

• Completed application form
• ID Proof – National ID/Driving License
• The Study Protocol
• Patient Information Leaflet and Informed consent form
• Investigators Brochure
• GMP Certificate
• Certificate of Analysis
• Current Practice License
• Signature

Office Locations & Contacts

Ministry of Health,
SLP 743, Dodoma, Tanzania
Phone: +255 262 323 267 / 5
Fax No: +255 262 342 000 / 5
Email Address: [email protected]
Contact link

Eligibility

• Any individuals in Tanzania who are in need of carrying out a clinical trial are eligible for this procedure.

Fees

• Fee for this procedure has to be paid as per the authority’s request.

Validity

• The validity period for a clinical trials letter of approval will be mentioned by concerned authorities.

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 will be mentioned by concerned authorities.

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.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

• Applicant should make sure to follow all instructions provided by concerned authorities.
• If any other documents are requested by concerned authorities during the time of application, it must be provided by the applicant.

Required Information

• Name of the Applicant
• Age
• Date of Birth
• Email Address
• Number of Sites
• Participants
• Group of Trial Subjects
• Gender
• Principal Investigator
• Scope of the Trial
• Design of the Trial

Need for the Document

• Approval of Clinical Trail is necessary for any individual for enacting clinical trial in Tanzania.

Information which might help

Enter other informations which might help.

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

• Ministry of Health link

Others

More information which might help people.