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Mind map

Amendment Submission

curare_sms Portuguese

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Amendment Submission

EC Submission
- Questions raised?
  - Yes
    - Site is required to reply
      - 30 days
        EC Evaluation
        30 days
        Questions Raised?
        Yes
        Repeat cycle
        NO
        Submission to National EC
        Docment Review
        15 days
        Documentation Passed?
        NO
        Package is returned
        Repeat cycle Submission to National EC
        Yes
        CONEP Evaluation
        60 days
        Questions Raised?
        Yes
        Site is required to reply
        30 days
        CONEP evaluation
        45 days
        Documentation passed?
        Yes
        Amendment approved
        NO
        Dossier is not approved and amendment is not implemented
        NO
        Amendment Approval
  - No
    - Submission to National EC
      - Document review
        15 days
        Documentation Passed
        Yes
        CONEP Evaluation
        60 days
        Questions raised?
        NO
        Amendment Approved
        Yes
        Site is required to reply
        30 days
        CONEP Evaluation
        45 days
        Documentation Passed?
        Yes
        Amendment Approved
        NO
        Dossier is not approved and ammendment cannot be implmented
        NO
        Package is returned
        Repeat cycle Submission to Nationa EC
- 30 days

Information

Description: Mind Map on Amendment Submission, created by curare_sms on 11/04/2014.
Created by: curare_sms
Views: 15
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