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The Pan African Clinical Trials Registry

The Pan African Clinical Trials Registry. A Tutorial: Simple Steps for Trial Registration. 1. Go to www.pactr.org to start. 2. Click on “register user” button. and complete all the fields to register yourself as a site user. 3. Email confirmation of new user .

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The Pan African Clinical Trials Registry

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  1. The Pan African Clinical Trials Registry A Tutorial: Simple Steps for Trial Registration

  2. 1. Go to www.pactr.org to start

  3. 2. Click on “register user” button • and complete all the fields to register yourself as a site user

  4. 3. Email confirmation of new user • You will receive an email asking you to activate your account by clicking on the link

  5. 4. Ready to Register? • Once you have received confirmation through the link (pictured to your right), your registration as a user is confirmed and you can begin to register your trial • Return to www.pactr.org and click the login button along the top tool bar • Complete the login form with your newly created User ID and password

  6. 5. Getting Started • Once you have logged in, you will need to click on the “register trial” button along the top toolbar • You will be asked to enter details about the trial, and should have information on the following topics available. 1. Basic Trial info; 2. Study Design; 3. Intervention; 4. Eligibility Criteria; 5. Outcomes; 6. Recruitment Centres; 7. Ethics Approval; 8. Funding Sources; 9. Sponsors; 10. Collaborators; 11. Contacts

  7. Getting Started, cont. • The status tracker is a useful tool located in my trials. • You can find the status tracker in the “my trials” button on the top toolbar • If any information is not immediately available, the “previous” and “next” buttons will help you move between pages

  8. 6. Trial Identification • Trial registration begins with trial identification • You will be asked to complete the following information: • Public Title • Official Title • Brief Summary • Acronym • Disease studied • Purpose of trial • Start Date • Completion Date • Target Sample Size • Recruitment status • Secondary ID • Secondary ID issuing authority

  9. 7. Study Design • You will be asked to fill in details of the design of the trial • You will be asked to complete the following information: • Intervention assignment • Allocation to intervention • Generation of allocation • Concealment of allocation • Masking used • Blinding used

  10. 8. Interventions • You will be asked to fill in details of the intervention • You will be asked to complete the following information for each arm of the trial: • Intervention type • Intervention name • Dose • Duration • Intervention description • Group size • Nature of control

  11. 9. Eligibility Criteria • Explains what makes a participant eligible for the study • You will be asked to complete the following information : • Inclusion Criteria • Exclusion Criteria • Minimum age (day/mo/yr) • Maximum age (day/mo/yr) • Gender

  12. 10. Outcomes • Explains what results the study is hoping to generate • You will be asked to complete the following information: • Type of outcome (primary or secondary) • Outcome • Timepoints to measure outcome • NB: To add more than one outcome, hit “add outcome” button and complete information for each intended outcome

  13. 11. Recruitment Centre(s) • Information on the places where respondents will be recruited • You will be asked to complete the following information: • Name of Centre • Street Address • City • Postal Code • Country • NB: To add more than one centre, hit “add recruitment centre” button and complete information for each intended centre

  14. 12. Ethics Approval • Complete information on applications for ethics approval • You will be asked to complete the following information: • Approval received • Date application submitted • Date approval confirmed • Name of ethics committee • Address of committee • Phone Number • City • Postal Code • Country

  15. 13. Funding Source • Disclose all funding sources and their contact details • For each funding source, you will be asked to complete the following information: • Name of source • Street address • City • Postal Code • Country • NB: To add more than one source, hit “add funding source” button and complete information for each source

  16. 14. Sponsors • Complete the details of all trial sponsors • For each sponsor, you will be asked to complete the following information: • Level of sponsorship • Name of sponsor • Street address • City • Postal Code • Country • Nature of Sponsor • NB: To add more than one sponsor, hit “add sponsor” button and complete information for each sponsor

  17. 15. Collaborator(s) • Provide names and contact details of all collaborators • For each collaborator, you will be asked to complete the following information: • Name • Street address • City • Postal Code • Country • NB: To add more than one collaborator, hit “add collaborator” button and complete information for each collaborator

  18. 16. Contacts • Each trial must provide information on three 3 contact people – the principle investigator, public enquiries, and scientific enquiries • For each contact person, you will be asked to complete the following information: • Role • Name (first and last) • Title • Email • Phone • Fax • Street address • City • Postal Code • Country • Position/affiliation

  19. 17. Data Complete? • Once you have completed all forms, and all mandatory data fields are complete, you will need to submit your trial’s information for review. • On the final form, the “contacts” page, you have the option of moving to a previous page or hitting the “submit” button. • Please ensure that you have completed all information before submitting to expedite the review process and ensure a quick response from the PACTR staff.

  20. 18. Additional Services • The PACTR site offers users some additional options aside from its registration service • Search options • Feedback/contact forms • Member profile • Useful Links • FAQs

  21. A. Search Options • PACTR’s database can easily be searched • At the moment, the database can be searched by disease type or keyword • Once you have hit the “search” button, the items returned will appear with easy links to the trial • NB: Search options are expanding – look out for advanced search options

  22. B. Feedback/Contact Forms • PACTR’s goal is to be user friendly. We provide feedback and contact forms so that our users can share their thoughts with us. We welcome comments.

  23. C. My Profile • This function allows you to maintain up-to-date contact information for the primary point person on the trial.

  24. D. Useful Links • The PACTR homepage provides useful links that will help a registrant complete the process and access relevant associated sites

  25. E. FAQs • Our frequently asked questions page has been compiled throughout the process of creating this database. • The FAQs page is meant as a quick and easy reference point for the site. • If there are questions that you feel should be included, please let us know

  26. Registration is Easy! But, if you have any problems, please do not hesitate to contact PACTR staff: • Site: www.pactr.org • Email: pactradmin@mrc.ac.za • Telephone: +27 (0)21 938 0506 • Postal Mail: PACTR c/o SACC at MRC PO Box 19070 Tygerberg 7505 Cape Town, South Africa

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