About CTF

Brief History of CTF

The Kemri-Wellcome programme in Kilifi has a long history of conducting clinical trials in illnesses that bring high disease burden and mortality in the community with which we work. We have a good balance of locally led 'academic' type clinical research and product development / drug registration trials. We have built up considerable experience from phase I through to evaluating real-life effectiveness in phase IV trials.

All trials are conducted to ICH-GCP and we manage them through a central system that shares resources and skills. Our Staff work across different trials where possible, and this gives them better opportunity to learn and allows us to share practices and materials. In addition the continuity this brings makes planning possible which enables us to properly resource all our trials and support the career development of our staff.

The clinical trial laboratory within the Kemri-Wellcome programme has full GCLP accreditation and our unit has been audited by the various regulatory bodies from the US and Europe. We work closely with the unit's research laboratory bringing a wide range of in-house expertise such as microbiology, immunology and pharmacology. The hospital also serves as a well-mapped Demographic Surveillance Site (DSS) where a census is conducted three times a year. This is of great benefit for planning and conducting trials.

Our Vision:

To be a global centre of excellence for the conduct of clinical trials.

Our Mission:

To ensure that our clinical trials capture high quality data and are conducted to the highest ethical standards. We strive to develop a cadre of skilled African clinical trialists to govern and lead our own research agenda.

CTF Staff:

CTF team comprises of highly skilled cadre of trialists and team members, which includes: Data team, Internal monitors, coordinators, lab team, pharmacy team, quality team and clinical team. Dr Patricia Njuguna is the acting Head of the Clinical Trials  Unit. Below is an attachment that elaborates the organization of CTF unit.

Why clinical trials?

It is important to continue doing research because "even the best proven prophylactic, diagnostic and therapeutic methods must continuously be challenged through research for their effectiveness, efficiency, accessibility and quality." (Declaration of Helsinki Intro Paragraph 6).

"The collection, analysis and interpretation of information obtained from research involving human beings contribute significantly to the improvement of human health." (CIOM11).

Our team of relentless clinicians, scientists and other highly qualified personnel put all their effort to provide quality clinical trials that are result oriented and respect motivated under the ICH/ GCP guidelines. Compassion and respect are our driving forces.

A word from the head of the Clinical Trials Facility

We are delighted to welcome you to our site. At the Clinical Trials Facility, quality standards are our obsession and we do go out of our way to ensure that this is reflected in all aspects of our work. The CTF enjoys the very rare privilege of being set in custom designed, state of the art buildings and endowed with the most wonderful group of hard working individuals one could dream of.

Please take time to run through the various sections of this site which will be revealing, but it is only the tip of the iceberg. We are situated on the hospital grounds of the rural District of Kilifi. Thanks to ICH-GCP, location does not matter anymore in research, but rather the quality of the work that is done.

Our business is to ensure that all clinical trials bearing the KEMRI-Wellcome Trust Research Programme logo meet the globally acceptable standards for conducting clinical trials. Our scientists leading the various fields of research are indeed world class, and have contributed significantly to current scientific evidence in field of tropical disease epidemiology, fluid management, care for the severely ill child, nutritional aspects as well a respiratory disease. When any of these programmes have need for conducting clinical trials, they come to the CTF. We also conduct clinical trials supported by external collaborators such as pharmaceutical industry, universities and other philanthropies.

At CTF we offer expertise for the design, regulatory/ethical aspects, implementation, monitoring and clinical data management. With a pool of experienced study coordinators, clinical monitors and data managers, we ensure that all aspects of an individual study comply to GCP and local regulatory requirements. We have recently implemented an quality assurance programme that ensures that we have a structured framework for maintaining our quality standards. We are also proud of the complement of clinical laboratories that are GCLP accredited.

Please come visit us whenever your road leads to the coast of Kenya.

Dr Patricia Njuguna

Acting Head of the Clinical Trials Facility

Approval process for conducting a trial

All research involving human participants is subject to regulation and approval by KEMRI, Ministry of Health and/or secondary Institutional Review Boards. It is the responsibility of the Principal Investigators to familiarize themselves with these policies and regulations prior to commencing any research and be aware of any changes thereafter. A record of decisions of the technical committees and any responses should be maintained in the main study file.

There are multiple steps of review before a trial can begin with an average turnaround time of about 6 months.

> STEP 1:

KEMRI Kilifi review committees

KEMRI Kilifi Programmet Management Committee (PMC) - (Meetings held every first Friday of the month)
The Kilifi PMC reviews all concepts intended for trial implementation. The concept proposal is written in standardized format. This review involves an overview of the study i.e. investigators, funding, study objectives, population, study design, duration and strategic implications and how protocol fits in the whole program. The concept is reviewed for potential interaction with ongoing or planned studies. After PMC approval the study can start the protocol approval processes described below. If the protocol is still in early development, the team can continue the protocol development process and later submit the protocol as described below at a later date.

> STEP 2

KEMRI Kilifi Scientific Review

KEMRI Wellcome Trust Kilifi - Scientific Centre Committee (SCC) Meetings held every first Friday of the month after PMC and KEMRI Wellcome Trust Kilifi - Consent and Communications Committee (CCC).

This committee does an indepth review of protocols which must be presented in a standard structured format, unless the sponsors/collaborators require a different format. The committee goe through a systematic review of all aspects of the proposed trial (Protocol, Investigator Brochure, Questionnaires, CRF, Information sheet and Lay Summary). The standard form has been developed to facilitate ethics and science review at the Kilifi SSC and anticipate areas of ethical and scientific discussion.

Protocols must be submitted to Kilifi SCC at least two weeks before the meeting. As per KEMRI guidelines, Kilifi SCC provides thorough review to protocols generated at the centre and ensure that protocols receive appropriate scientific and ethical input. The KEMRI Wellcome Trust Kilifi unit has two committees for this purpose, the SCC which mainly reviews scientific integrity and ethics and the CCC which reviews consents After review at the Kilifi SCC, the informed consent is reviewed by the Kilifi CCC on the following Tuesday. Where the Kilifi SCC decision is favorable to continue IRB/ERC reviews, the investigator will complete a KEMRI Forwarding Form for submission to KEMRI SSC. In addition to the protocol, informed consent and translations (except if exempt), and where applicable, Investigator Brochure, any recruitment material including videos for approval by KEMRI IRB/ERC.

> STEP 3

KEMRI Nairobi Scientific Review

A protocol approved by the Kilifi SCC is submitted to the KEMRI Nairobi SSC through the Centre Director using the official KEMRI Forwarding Form. KEMRI also specifies who qualifies as an investigator. These reviews are also conducted monthly at pre-scheduled meetings. (The dates for their meetings are available upon request)
The decision of the KEMRI SSC may be to approve the protocol and forward it to KEMRI ERC or obtain the investigator's specific responses to reviewer comments before approving the protocol. After review by KEMRI SSC, the protocol is given a KEMRI SSC study number which should be referenced for any future correspondence with KEMRI.

The investigator may notify the KEMRI SCC if there are
any new amendments to the protocol. Depending upon the changes required you may need to change the version of the protocol or informed consent.

> STEP 4

KEMRI Ethics Review Committe

KEMRI ERC meetings are held monthly, usually two weeks after KEMRI SSC meetings and their meetings schedule is also available upon request. KEMRI Nairobi ERC reviews all research protocols that involve human subjects. The KEMRI ERC mainly reviews the ethical aspects of the protocol, storage of samples, exportation of samples, future research and also any other aspects of the proposal relevant to KEMRI. The decision of the ERC may be approval to start the study or further correspondence with the investigator prior to approval.

After receiving the KEMRI ERC approval non-clinical trial research may be able to recruitment, however, clinical trials involving medicinal products must go through the fifth and final review.

> STEP 5

Pharmacy and Poisons Boards Review

Pharmacy and Poisons Board Expert Committee on Clinical Trials (ECCT) reviews and approves all clinical trials in Kenya and providing import licenses for study drugs. A checklist of required documents and schedule of meetings is available on the web site http://www.pharmacyboardkenya.org/. They PPP does not have a fixed submission schedule, but generally completes their review within about a month.

After approval - (Continuing Review and Renewal Request)
After receiving all approvals as required for the study, field or hospital recruitment activities may then start. Please check the expiry dates of the approvals. Usually approvals are given for one year or less depending on the type of research. Approvals are subject to renewal upon submission of annual Continuing Review Report and request for approval renewal.

It is the responsibility of the PI to report any changes in research activity and provide amendments and consent form changes to KEMRI for approval prior to initiating these changes unless the changes impact on safety of participants.

Failure to comply with regulatory authority policies and regulations can result in study suspension, termination and possible disciplinary action on the part of the investigator.

Professor Kathryn Maitland

Quality policies and SOPs

We have developed in house standards and policies which are available on our intranet or upon request by interested parties. Their purpose is to govern and assure quality is achieved and maintained, and that all regulatory requirements are adhered to. These sets of policies and standard operating procedures (SOP) are reviewed and updated regularly and currently they include:

POL- 001 Health and Safety
POL- 002 Training
POL- 003 Quality Improvement
POL- 004 Clinical Lab Management

CTF's SOPs cover the following areas:

1. Administrative

SOP 1.0 Preparation, Approval, Review and Issue of clinical trial SOP
SOP 1.1 CTF Standard of operation
SOP 1.2 Pharmaceutical product management and accountability
SOP 1.3 Preparing a trial budget and contract

2. Regulatory and QA

SOP 2.0 Protocol generation and submission
SOP 2.1 Informed consent
SOP 2.2 Consent on HIV screening
SOP 2.3 Participant confidentiality

3. Clinical Trial conduct

SOP 3.0 Study initiation procedure
SOP 3.1 Good documentation practices
SOP 3.2 Adverse/ Serious Adverse Events (AE/ SAE)
SOP 3.3 Phlebotomy
SOP 3.4 Ongoing trial management
SOP 3.5 Monitoring
SOP 3.6 Data entry and management
SOP 3.7 Community engagement and MOH liaison
SOP 3.8 Study close out

Current and planned clinical trials