step-by-step guide - Pan African Clinical Trials Registry

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.
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Basic Trial info;
Study Design;
Intervention;
Eligibility Criteria;
Outcomes;
Recruitment Centres;
Ethics Approval;
Funding Sources;
Sponsors;
Collaborators;
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
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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
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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:
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Intervention type
Intervention name
Dose
Duration
Intervention description
Group size
Nature of control
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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
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Information on the places where respondents will be recruited
You will be asked to
complete the following
information:
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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
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Disclose all funding sources and their contact details
For each funding
source, you will be
asked to complete the
following information:
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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
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Complete the details of all trial sponsors
For each sponsor, you
will be asked to
complete the following
information:
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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
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Provide names and contact details of all collaborators
For each collaborator,
you will be asked to
complete the following
information:
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Name
Street address
City
Postal Code
Country
‣ NB: To add more than
one collaborator, hit “add
collaborator” button and
complete information for
each collaborator
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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:
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Role
Name (first and last)
Title
Email
Phone
Fax
Street address
City
Postal Code
Country
Position/affiliation
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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.
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The PACTR site offers users some additional
options aside from its registration service
◦ Search options
◦ Feedback/contact forms
◦ Member profile
◦ Useful Links
◦ 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
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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.
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This function allows you to maintain up-to-date contact
information for the primary point person on the trial.
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The PACTR homepage provides useful links that will
help a registrant complete the process and access
relevant associated sites
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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:
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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