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Overview & New Application

What are Clinical Trial (CTF1) Applications?

The CTF1 application is the standard form used to request authorization from SAHPRA to conduct a clinical trial involving human participants in South Africa. Any research involving investigational medicinal products must undergo rigorous regulatory and ethical review to ensure the safety, rights, and well-being of participants, as well as the scientific integrity of the trial data.

Types of Clinical Trial Applications & Fee Categories

When creating a new CTF1 application, applicants must select the appropriate category based on the nature and funding of the study to determine the application fee:

  1. New Clinical Trial Application – Standard Typically applies to commercially sponsored, industry-initiated clinical trials (Phases I, II, and III). These are standard trials investigating new active pharmaceutical ingredients (APIs), new formulations, or new indications.

  2. Postgraduate Study with Pharmaceutical Company Involvement Applies to Investigator-Initiated Trials (IITs) conducted by a student for a postgraduate degree (e.g., MMed, PhD), but where a pharmaceutical company provides support (e.g., funding or Investigational Product supply).

  3. Phase IV / Academic / Postgraduate (Non-Commercial) Applies to purely academic, grant-funded, or postgraduate research with no commercial pharmaceutical backing. It also applies to Phase IV (post-marketing) clinical trials involving SAHPRA-registered medicines used strictly within their approved indications.

Application Process Overview

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flowchart TD
    A[Start Application] --> B[Select CTF1 Category & Fee]
    B --> C[Complete Sections A-L]
    C --> D[Upload Supporting Documents]
    D --> E[Submit & Generate Invoice]
    E --> F[Process Payment]
    F --> G[Admin Screening*]
    G --> H[Administrative Review]
    H --> I[Statistical Review]
    I --> J[Committee Meeting*]
    J --> K[Approval & Outcome Letter]
    
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    %% Apply it to the legend box to make it stand out
    L[*Indicates stages where application can be queried]:::highlight
    
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Creating a New CTF1 Application

Initiating a new Clinical Trial application follows a guided step-by-step process on the portal.

Step 1: Initiate the Application

  1. Log in to the SAHPRA portal.
  2. Navigate to the Applications menu and select My Applications.
  3. Click the Create New Application button.
  4. Select Clinical Trial Application from the available types and proceed.

Step 2: Select Application Category

Choose the appropriate fee category based on the nature of your study (Standard, Postgraduate with Company Involvement, or Academic/Non-Commercial). This selection directly impacts the required fees generated at the end of the process.

Step 3: Complete the Form Sections (A-L)

The CTF1 form is divided into several sections. You must complete each section sequentially or save your progress as a draft. Key sections include:

  • Section A: Administrative Details (Protocol info, Sponsors, Applicant, PI, Monitors).
  • Section B: Trialists and Sites (Adding existing or new sites, staff details, laboratory competence).
  • Section C: Regulatory Details (Status with other authorities, ethics committees).
  • Section D: Investigational Product (IP details, manufacturing, stability, importing rationale).
    • Note: API Manufacturer Information uses a specific search function. Read more about it here.
  • Sections E-L: Background, Objectives, Methodology, Eligibility, Safety Monitoring, Statistical Measures, and Ethical Issues.

Step 4: Upload Supporting Documents

Throughout the application, you will be prompted to upload various supporting documents (PDF, DOC, ZIP).

  • Tip: Rename any uploaded files to contain the application number (e.g., Protocol_V2_CTF00000010.pdf) to prevent delays during administrative screening.

Step 5: Review and Submit

Review all entered information and uploaded documents for accuracy. Once verified, submit the application to generate an invoice.

Step 6: Process Payment

  1. After submission, an auto-generated invoice and order number will be created based on your selected fee category.
  2. This order number must be used as the beneficiary reference number on your proof of payment (EFT).
  3. Upload and submit your proof of payment via the portal.

Key Information Required

  • Application Category (Dropdown)
    • Options: New Clinical Trial Application – Standard, Postgraduate Study with Pharmaceutical Company Involvement, Phase IV / Academic / Postgraduate (Non-Commercial)
  • 1.1 Study Title (Text input)
  • 1.2 Protocol Details
    • Protocol No (Text input)
    • Version (Text input)
    • Date (Date picker)
  • 1.3 Phase of Trial (Text input)
  • Protocol Document (File upload: PDF, DOC, ZIP)
  • 1.4 Sponsors/Funders
    • Specify Sponsor/Funder (Text input)
    • Select Role/Input Role (Text input)
    • Therapeutic area (Text input)
  • 1.5 Applicant (Text input)
  • 1.6 Contact Person
    • Name, Contact Number, E-mail Address (Text inputs)
    • Physical Address Details (Unit, Floor, Building, Street, Suburb, City, Province, Country, Postal Code)
  • 1.7 National Principal Investigator/Coordinator (Text input)
  • 1.8 Regional Monitor
    • Full Name, Contact Number, Email Address (Text inputs)
    • Physical Address Details
    • Staff Documents for regional monitor: CV, declaration, GCP (File upload: PDF, DOC, ZIP)

Note: You can add an existing site or create a new site via linked forms.

  • 2.1 Details of Site
    • Name of Site, Contact Person, Contact Number (Text inputs)
    • Physical Address Details
  • 2.2 Site Selection
    • Details of how the site was selected (Text area)
    • Evidence of accreditation/Certifications of the designated laboratories (File upload: PDF, DOC, ZIP)
  • 2.3 Details of Investigators and Staff
    • Name, Role, Qualification, Provider of GCP training (Text inputs)
    • Expiry date of GCP Training & Malpractice insurance cover expiry (Date pickers)
    • Investigator and Staff Documents: CV, declaration, workload, GCP, registration, insurance, dispensing license (File upload: PDF, DOC, ZIP)
  • 2.4 Details of capacity of site
    • Site Facilities, Equipment, Emergency Facilities, Other Relevant Infrastructure (Text area)
  • 2.5 Details and evidence of competence of laboratories
    • Collection and processing of samples (Text area)
    • Bedside/point-of-contact testing and staff training (Text area)
    • Screening and safety testing (Text area)
    • Specialised end-point testing (Text area)
    • Name and details of the organisation(s) (Text area)

Note: Regulatory or Ethic Committees are added via linked forms.

  • 3.1 Regulatory Authorities
    • Name other Regulatory Authorities to which application has been submitted/approved (Text area)
  • 3.2 Status of Application with the Regulatory Authority/Ethics Committee (Dropdown)
    • Options: Submitted, Approved, Rejected (Requires reason), Other (Requires status)
  • 3.3 Trial Location Justification
    • Explanation if trial is in SA and not host country (Text area)
  • 3.4 Halted Trials
    • Details/reasons for trial halted by other Regulatory Authorities (Text area)
  • 4.1 Active Substance Origin
    • Does IP contain chemical or biological/biotechnological origin? (Text input)
  • 4.2 Details of IP (Added via Linked Forms)
    • Name of IP, Mode of Administration, Formulation, Strength, Unit of Measurement, Dosage Unit, Dosage Interval, Duration of treatment, Additional Details (Text inputs)
  • 4.6 Properties of IP
    • Mechanism of action (Text area)
  • 4.7 Pre-clinical findings
    • Summary of laboratory/animal/toxicity/mutagenicity (Text area)
  • 4.8 Concomitant medication(s)
    • Name, Rescue Medication Required/Excluded, Additional Details (Text inputs)
  • 4.9 IP Modification
    • Is the IP modified in relation to its original registration? (Yes/No)
  • 4.10 Estimated Quantity
    • Quantity of Trial Material including overage justification (Text area)
  • 4.11 Import Justification
    • Explanation why IP needs to be imported if available in SA (Text area)
  • 4.12 Supply Management
    • Details of receipt, storage, dispensing, packaging, labelling, preparation, handling (Text area)
  • 4.13 Intention to Register (Yes/No)
  • 4.14 Manufacturing and Stability
    • Details of Manufacturing, Quality Control, and Stability/Destruction (Text areas)
    • Certificate of GMP (File upload: PDF, DOC, ZIP)
  • 4.15 Previous SAHPRA Approved Studies
    • Approval Number, Study Title, Protocol Number, Dates, PI, Report Dates (Text inputs/Date pickers)
  • 5.1 Disease/problem in SA context (Text area)
  • 5.2 Overall rationale for the study (Text area)
  • 5.3 Rationale in SA context (Text area)
  • 6.1 Primary objectives and endpoints (with justifications) (Text area)
  • 6.2 Secondary objectives and endpoints (with justifications) (Text area)
  • 6.3 Tertiary Objectives and endpoints (with justifications) (Text area)
  • 6.4 Exploratory objectives and endpoints (with justifications) (Text area)
  • 6.5 Safety objectives and endpoints (with justifications) (Text area)
  • 7.1 Study Design
    • Choice of design, Phase, placebo use, dosages, randomisation, blinding, duration (Text area)
  • 7.2 Duration of overall study (Text area)
  • 7.3 Planned Dates (Local)
    • End of recruitment, Planned Start, Stop date (Date pickers)
  • 7.4 Planned Dates (Global)
    • Planned Start, Stop date (Date pickers)
  • 7.5 Participant Numbers
    • Global and Local participant totals (Numeric inputs)
    • Competitive study? (Yes/No)
    • Competitive enrolment? (Yes/No)
    • Participants per local site (Sites specified in section B)
  • 7.6 Site Recruitment Potential
    • Information indicating potential of each site to recruit (Sites specified in section B)
  • 7.7 Sub-studies
    • Details of pharmacogenetic, biobanking or other sub-studies (Text area)
  • 8.1 Inclusion Criteria (Text area)
    • Age Group (Checkboxes: Neonates/Infants, Children/Toddlers, Children, Adolescents, Adults, Geriatric)
    • Gender (Male, Female, Both)
    • Includes pregnant females? (Yes/No)
    • Includes lactating adults? (Yes/No)
    • Includes HIV positive individuals? (Yes/No)
    • 8.1.1 Justification (Text area)
  • 8.2 Exclusion Criteria (Text area)
    • Age Group & Demographics (Same as Inclusion Criteria)
    • 8.2.2 Justification (Text area)
  • 9.1 Data and Safety monitoring plan
    • Description of plan and site oversight (Text area)
    • Monitoring plan (File upload: PDF, DOC, ZIP)
  • 9.2 Data Safety Monitoring Committee
    • Details of Composition, Affiliations, Charter, Stopping rules (Text area)
    • DSMB charter and composition (File upload: PDF, DOC, ZIP)
  • 9.3 Interim analyses
    • Details of planned interim analyses (Text area)
  • 9.4 AE and SAEs
    • Definitions, reporting guidelines, causality assessments, and AEs of special interest (Text area)
  • 10.1 Sample size determination
    • Justification of study power vs outcome measures (Text area)
  • 10.2 Statistical method(s)
    • Analysis of measures with justification (Text area)
  • 10.3 Details of data processing (Text area)
    • Statistical Analysis Plan (File upload: PDF, DOC, ZIP)
  • 11.1 GCP Deviation
    • Justification for deviation from SA GCP (Text area)
  • 11.2 Capacity Building
    • Details of transformation at all sites (For sites specified in section B)
  • 11.3 Insurance Details
    • Insurer, Protocol, Dates, Policy Number, Patient Amounts, Vendor, Patients Covered (Text/Numeric inputs)
    • Active Insurance Certificate (File upload: PDF, DOC, ZIP)
  • 11.4 Indemnity
    • Details for Investigators and site (Text area)
    • Proof of Sponsor Indemnification (File upload: PDF, DOC, ZIP)
  • 11.5 Malpractice Insurance
    • Confirmation of current insurance for investigators (Text area)
  • 11.6 Informed Consent
    • Upload Informed Consent Form (File upload: PDF, DOC, ZIP)
    • Upload other participant material (File upload: PDF, DOC, ZIP)
  • 11.7 Publication Policy (as per ICJME) (Text area)
  • 11.8 Participant Remuneration (Text area)
  • 11.9 Investigator Remuneration (Text area)
  • 11.10 Ethics Committees
    • List of committees approving the study (For sites specified in section C)
  • 11.11 Conflict of Interest (Text area)
  • 11.12 Post Trial Medicine Access
    • Provided after completion? (Yes/No)
    • Details of management (Text area)
  • Final Uploads for Section K:
    • Recruitment Advertisements & Questionnaires (File upload)
    • Peer reviewed publications (File upload)
    • Ethics Approval Letter (File upload)
    • Study Budget (File upload)
  • Additional Information
    • Any other relevant information supporting the study (Text area)
    • Additional documents (File upload: PDF, DOC, ZIP)

Supporting Documents Checklist

Below is the comprehensive list of documents you will be prompted to upload throughout the application. Please ensure these are ready in PDF, DOC, or ZIP format:

Protocol & Study Design - Full Trial Protocol Document (Section A) - Statistical Analysis Plan (SAP) (Section J) - Investigator’s Brochure (IB) or Professional Information (PI)

Investigator & Site Documents - Regional Monitor Documents (CV, Declaration, and valid GCP Certificate) (Section A) - Investigator and Staff Documents (Must be scanned into one document containing: CV, declaration, workload, GCP certificate, proof of statutory registration, malpractice insurance, and dispensing license where applicable) (Section B) - Evidence of Laboratory Accreditation/Certifications (Section B)

Safety & Data Monitoring - Study Monitoring Plan (Section I) - Data Safety Monitoring Board (DSMB) Charter and Composition (Section I)

Investigational Product (IP) - Certificate of GMP for IP manufacturing site(s) (Section D)

Participant Materials - Patient Information Leaflet and Informed Consent Form(s) (Section K) - Other Participant Materials (e.g., diary cards, patient cards) (Section K) - Copy/ies of Recruitment Advertisements and Questionnaires (Section K)

Ethics, Insurance & Financials - Ethics Approval Letter or Proof of Submission to an Ethics Committee (Section K) - Active Insurance Certificate for the Clinical Trial (Section K) - Proof of Sponsor Indemnification for Investigators and Trial Site (Section K) - Study Budget (Section K)

Additional Literature & Extras - Electronic copies of key peer-reviewed publications following ICMJE recommendations (Section K) - Any other additional supporting documents (Section L)

Post-Submission: Payment Issues and Review Timeframes

Submitting a Revised Proof of Payment

If you receive an email stating that your payment was disputed for an application, you can submit a new proof of payment directly through the portal:

  1. Navigate to the Applications Dashboard.
  2. Locate the relevant application.
  3. Click the View button to the right of the application.
  4. Select the Payment Tab in the top right corner.
  5. Upload and Submit your new proof of payment.

To initiate a refund, refer to the SAHPRA Payment Guideline

Review Stages and Processing Timeframes

Once payment is approved, your application progresses through the following review stages:

  1. Admin Screening *
  2. Administrative Review
  3. Statistical Review
  4. Reviewed in a Meeting *

Note: All stages marked with an asterisk (*) are points where the application can be queried and sent back to the applicant for review or clarification. Official processing timelines do not include the time an application spends in a queried state.

Outcome Letter

Once a final decision is reached (approved or rejected), a Signed Outcome Letter is generated.

  • This letter will reside in the Application Documents section of the specific application.
  • To access it, locate the application in your Application Manager and click on the Overview action button on the right-hand side.