A Tutorial: Simple Steps for Trial Registration

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and complete all the fields to register yourself as a site user

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You will receive an email asking you to activate your account by clicking on the link

▶ 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

▶ 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

▶ 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

 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

 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

▶ 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

 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

▶ 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

 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

 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

 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

 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

 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

 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

 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.

 ◦ The PACTR site offers users some additional options aside from its registration service

Search options

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Feedback/contact forms

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Member profile

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Useful Links

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FAQs

 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

 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.

 This function allows you to maintain up-to-date contact information for the primary point person on the trial.

 The PACTR homepage provides useful links that will help a registrant complete the process and access relevant associated sites

 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

But, if you have any problems, please do not hesitate to contact PACTR staff:     Site:

www.pactr.org

Email:

[email protected]

Telephone: +27 (0)21 938 0506 Postal Mail: PACTR c/o SACC at MRC PO Box 19070 Tygerberg 7505 Cape Town, South Africa