NCTR

Frequently Asked Questions and Answers

What is the Nigeria Clinical Trials Registry? 
The Nigeria Clinical Trials Registry (NCTR) is a Nigerian initiative to support clinical trial registration. The NCTR provides data to the central Pan African Clinical Trials Registry (PACTR) so that trials registered in the NCTR are represented on the platform.

What are the aims of the Nigeria Clinical Trials Registry? 
The Registry aims to:

1. Provide a repository for prospective registration of clinical trials conducted in Nigeria
2. Promote prospective clinical trial registration in Nigeria
3. Ensure the WHO-stipulated minimum dataset for registered trials is publicly and freely available to all users of the registry
4. Provide a searchable database of all clinical trials conducted in Nigeria.

The Nigeria Clinical Trials Registry aims to increase the number of trials in Nigeria that are registered prospectively.

What does it mean to be a member of the WHO Network of Primary Registers (NPR)? 
Primary registry status is granted by the WHO only to registries who meet specific criteria for content. Criteria are separated into six categories, namely, content, quality and validity, accessibility, unique identification, technical capacity and administration, and all categories must be met in order to receive primary registry status. WHO primary registries meet the requirements of the ICMJE which stipulate that in order to be published in a member-journal, registration is mandatory.


How will the information contained in the registry be useful?
The Nigeria Clinical Trials Registry will be an important global resource for researchers, clinicians, policy makers and the lay public by:

1. Providing a source of reliable information on the efficacy and safety of prevention and treatment measures
2. Identifying research gaps that should be addressed in future trials
3. Providing a "laboratory" for studying the scope, quality and funding patterns of trials
4. Keeping track of on-going trials
5. Ensuring effective allocation and use of limited research funding
6. Decreasing wasteful duplication of research
7. Promoting research collaboration within the region
8. Providing a potential means of regulating clinical trial activity in Africa.

The Nigeria Clinical Trials Registry is unique in recognising that African trialists face additional challenges in trial registration and seeks to provide feasible ways of overcoming these. Due to the limited and unreliable access to the internet experienced by individuals in a number of African countries, trials may be registered online, (via the internet if access is sufficiently reliable) or by email, postal mail or facsimile. 


What is a clinical trial?
There are many definitions of clinical trials. In general clinical trials are biomedical or health-related research studies in human beings that follow a pre-defined protocol. A clinical trial is prospective research designed to evaluate the safety and/or effectiveness of drugs, medical devices, treatments or preventive measures in humans. For more information see World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) or the Ottawa Statement 

Since clinical trials have been variably defined, it is important for NCTR to clearly state what we include in our definition. 


How does the NCTR define clinical trials? 
NCTR accepts interventional RCTs and CCTs, pharmacokinetic and pharmacodynamic studies on its registry (including phase 1 - 4 trials).

A Randomized Control Trial (RCT) is a trial in which participants are randomly allocated to one of two or more intervention arms allocating people to groups using a method based on chance (e.g., random number table, random computer-generated sequence, minimization, adaptive randomization). The control group is usually given either the standard intervention for the disease in question or a placebo while the other group (or groups) is assigned to the experimental arm(s) (drug or other intervention).

A Controlled Clinical Trials (CCT) is a trial in which participants are allocated to one of two or more intervention arms allocating people to groups using a method not based on chance (e.g., birthdate, day of the week registered, etc.). The control group is usually given either the standard intervention for the disease in question or a placebo while the other group (or groups) is assigned to the experimental arm(s) (drug or other intervention).

What does the NCTR exclude from its definition of clinical trial? 
Observational studies which are studies in which individuals are observed and their outcomes are measured by the investigators. 


Why is it important to register your clinical trial? 
There are both ethical and scientific reasons for registering trials. People who participate in clinical trials expect their contributions to be made use of in improving health care for everyone. Open access to information about ongoing and completed trials will satisfy the ethical duty to trial participants and will promote greater trust and public confidence in clinical research. Clinical trial registration in open access registries will also reduce selective publication of trial results. In addition to this clinical trial registration will decrease wasteful duplication of research, promote international research collaboration and ensure more efficient and effective allocation of research funds. 


What is a clinical trial register? 
A clinical trial register is essentially a database that contains pertinent information (both administrative and scientific information) on each registered trial. 


Which trials may be registered with the Nigeria Clinical Trials Registry? 
All clinical trials conducted in Africa may be registered in the Nigeria Clinical Trials Registry. We encourage the registration of early phase trials and pilot studies. 


What do I need to know before I register my trial? 

• You must register as a user on the Nigeria Clinical Trials Registry
• The trial you want to register must be an interventional clinical trial.
• Trial registrants must be provide copies of ethics approval
• You must have all the information to be able to complete the WHO dataset . All NCTR fields must be completed before a NCTR trial number is assigned.
• You must be registering the trial before enrolment of the first participant to meet the publication pre-requisites of the International Committee of Medical Journal Editors (ICJME) to publish in any of their member-journals

If the trial is already registered with a Primary or Partner register within the WHO ICTRP Registry Network, must the trial be registered again with the Nigeria Clinical Trials Registry? 
If your trial is already registered with a WHO Primary Register, there is no need to register the trial again with the Nigeria Clinical Trials Registry. If you have registered your trial in a registry that is not acknowledged within the WHO ICTRP Registry Network, it would be advisable to register with one of these in order to ensure that you fulfill journal requirements. 


Who should register the trial?
It is recommended that the trial sponsor register the trial. However trial coordinators or principal investigators may also register the trial. For multi-site studies trial data should be submitted only once. (Do not submit trial data for each study location). 

The trial registrant is responsible for:

• the accuracy and completeness of registered data
• ensuring that information on any one trial is submitted only once
• communicating with trial collaborators regarding the registration status of the trial, and the registration number
• ensuring information on the registered trial is kept up-to-date

When should a trial be registered? 
Ideally, trials should be registered before the enrolment of the first participant. Trials may be registered either before or after receiving regulatory and/or ethics approval. 


How do I register a trial with the Nigeria Clinical Trials Registry? 
(see how to register a trial page) 


What information do I need to register a trial?

• Title of trial 
• Trial acronym (if available) 
• Trial objective 
• Inclusion and exclusion criteria of participants 
• Target number of participants required (sample size) 
• Anticipated start date 
• Disease or condition 
• Information on interventions (name, dose, duration) 
• Primary outcome(s) 
• Secondary outcome(s) 
• Location of primary recruitment centre 
• Contact details of person(s) responsible for providing information about the trial to the public and the scientific community 
• Source(s) of Monetary or Material Support
• Primary Sponsor
• Information on collaborators (name, address, country) or  Secondary Sponsor(s) 

Should pilot studies be registered? 
We encourage the registration of pilot studies 


Does the Nigeria Clinical Trials Registry comply with the requirements set out by the International Committee of Medical Journal Editors in their September 2004 and May 2005 editorials? 
Yes 

Is there a fee to access information on the registry and/or to register a trial? 
Access to information in the registry and trial registration is free of charge.Users can search the registry without registering as a user via the search function. 

If I forgot my password how do I obtain this information? 
Go to the LOGIN page on the portal. Click on "Forgot your password". Enter either your User ID or your Email address and click on "Reset password".

Your reset password will be mailed to you to the email address you provided during registration. Please go and review this email to retrieve your new password. Once you login you can navigate to the "MyProfile" page to change your password.

How can I refine a search? 
A search can be refined using the advanced search option. In order to access the advanced search, first click on the search link on the homepage. From there, you will see a link to advanced search. This will allow you to refine your search options. 

Why is my advanced search not working? 
One reason you may be having difficulty with the advanced search function is that in order for the search to be conducted you must remember to click in the tick boxes in order for a particular field to be searched. 

I submitted my application a number of days ago, why have I not heard anything back? 
If your application was submitted more than a week ago and you have yet to receive any correspondence from us, then you should check two things:

1. Please remember that if you have left any fields blank, your application will not be formally reviewed. All fields must be completed in order for your application to begin the review process.
2. When you complete your application, please be sure to navigate to the "submit" button on the last page of information. This button will alert a site administrator that your application is ready for review.

Why is my data not being saved to the trial profile? 
When you are navigating from page to page while filling in the data, please be sure to navigate using the next button at the bottom of the page. By hitting the next button, your data is sent through to the database and then saved. If you are navigating between pages using any other means (including the trial tracker function) then your data will not be saved.