J.3 - Task Order for Program Activities.doc

Attachment 3

Request for Task Order Proposal

Task #3 - Program Activities in Kenya *This is a firm fixed price task order.*

Task Order Title: Protocol/Clinical Trial Monitoring Services in Kenya Background On July 30, 2008, H.R. 5501, the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 was signed into law, authorizing up to $48 billion over the next 5 years to combat global HIV/AIDS, tuberculosis, and malaria.

In 2003, the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) was launched to combat global HIV/AIDS, the largest commitment by any nation to combat a single disease in history. The initial legislative authorization for PEPFAR is P.L. 108-25, the United States Leadership Against Global HIV/AIDS, Tuberculosis, and Malaria Act of 2003. PEPFAR was created to increase HIV prevention and treatment programs in 15 countries in Africa. Since 2004 there has been a rapid scale-up in treatment programs in all PEPFAR-funded nations.

Through FY2013, PEPFAR plans to work in partnership with host nations to support:

(a) Treatment for at least 3 million people

(b) Prevention of 12 million new infections

(c) Care for 12 million people

The Centers for Disease Control and Prevention (CDC), Division of Global AIDS (DGA) supports the development of sustainable public health capacity to effectively deliver HIV care and treatment services, in order to ensure the long-term impact of PEPFAR.

Purpose/Need

Areas have been identified within the delivery services of the local partner organizations in South Africa, Kenya, Ethiopia, Nigeria, Uganda, Mozambique, Botswana, Tanzania, Cote d’Ivoire and/or Central America, where assistance is required to ensure the rights of human subjects are protected. Assistance is also needed to validate the data collection and monitor adherence to protocols. The purpose of this task order is to ensure compliance with 45CFR 46, Good Clinical Research Practice (GCP) and other applicable guidelines, policies and regulations of DHHS and FDA. Monitoring requires data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, and protection of human subjects in Kenya. Monitoring and the method chosen must be commensurate with the degree of risk.

Contractor services shall include but are not limited to: (1) monitoring existing clinical sites; (2) providing technical assistance to staff at the local sites; and (3) collaboration with local staff to ensure protection of human subjects. In order to assure that these projects are conducted in an ethically sound and scientifically rigorous manner, CDC is requesting an external group to monitor international projects under this contract. The contractor will assess documentation in Kenya by evaluating the records of enrolled subjects. Subsequent monitoring visits will be conducted in accordance with the design and complexity of the clinical projects. We anticipate there will be a total of 4 visits to each site. The sites include Nairobi, Kisumu, Mobasa and Nakuru. The ultimate purpose of this contract is twofold: (1) to monitor the sponsored clinical trial in a resource limited setting and (2) to ensure activities are conducted in an ethical and scientifically rigorous manner In according to the Department of Health and Human Services, Office of Human Research Protection, Scope of Work: The Contractor shall provide the following services and perform the following tasks in Kenya, with deliverables as shown below:

A. Task #1: Conduct Pre-Study Visit/Initiation Site visit

The Contractor shall provide the following services in Kenya:

Within 60 days of the contract award, the contractor shall make one pre-study visit each of the the clinical trial site(s) in the four cities to ensure their preparedness and adequacy to undertake the trial. To accomplish this task the contractor shall at a minimum:

a. Collect specific baseline information regarding the site(s) overall organization, site operations and plans for implementation of the study. This shall include the review of study personnel, their roles and responsibilities, and facilities and resources.

b. Assess staff qualifications and training to perform the specified activities.

c. Review the overall clinic space and waiting areas including: availability of a private area for patient consultation; availability of locked file cabinets for record storage; and overall adequacy of the facilities.

d. Assure that secure space is available for sensitive documents such as randomization lists.

e. Verify that patient confidentiality is adequately maintained and that linkage of the subject’s name and study code will be kept in a locked file or drawer, separate from the data records.

f. Evaluate study implementation plans, procedures and logistics.

g. Provide guidance on policy, availability and adequacy of procedures, good clinical practice and internal quality management plans.

h. Conduct assessments and evaluations necessary to ensure technically and ethically sound research is proposed in accordance with guidelines of the Department of Health and Human Services, Office of Human Research Protection 45 CFR 46.

Reporting Requirements

Within two weeks of the close of the pre-study /initiation visit in each city , the contractor shall provide an electronic copy of the draft site visit report from each site visited to the CDC. This will be a total of 4 individual site visit reports. The reports shall include specific recommendations based on a review of all study documents and findings. The report shall be written in Microsoft Word (latest version).

CDC COTR shall review the draft report and provide comments and recommendations to the contractor within one week of receipt. Within four weeks of the close of all pre study/initiation visits, the contractor shall provide an electronic copy of one comprehensive prestudy report to the CDC Contracting Officer Technical Representative (COTR).

Deliverables

Table 1 Task #1 Deliverables

B. Task #2 Conduct interim monitoring visits in Kenya The contractor will provide local travel for monitors to visit each site: Nairobi, Kisumu, Mobasa and Nakuru. Monitors will conduct a minimum of two interim visits to each site (for a total of 8 interim visits and (1) adequately prepare for site visits, (2) travel to Kenya, districts, localities, (3) review 100% of the informed consent forms, (4) randomly check data abstraction from medical records, (5) observe the data collection process, (6) compare data captured on paper study forms against electronic databases for a sample of study participants, and (7) debrief, summarize visits, and write the reports. (total of 8) To accomplish this task, the contractor shall:

a. Reassess the adequacy of facilities and staffing, including changes in personnel;

b. Verify proper adherence to the protocol;

c. Verify the accuracy and timeliness of adverse event reporting;

d. Verify timely submission of protocol amendments to the IRB, if applicable, and any approvals;

e. Verify the maintenance of accurate, complete and current regulatory records;

f. Verify the maintenance of accurate, complete and current clinic reports;

g. Verify that signed informed consent is on file for all enrolled study subjects, including verification that the document is properly completed and the informed consent process is appropriately documented in clinic records;

h. Verify that all (or a sample as specified in the monitoring plan) of participants meet eligibility criteria before enrollment into the study; and

i. Review data collection forms for legibility, completeness, accuracy and the proper documentation of any data change, and compare with data captured in an electronic database.

Reporting requirements

Within two weeks of each interim monitoring site (8) visit the contractor shall provide an electronic copy of the t site visit report to the COTR. The report shall include specific recommendations based on a review of all study documents and findings. The report shall be written in Microsoft Word (latest version).

CDC shall review the draft reports and provide comments and recommendations to the contractor within one week of receipt.

Deliverables

Table 2 Task #2 Deliverables

C. Task #3 Conduct close-out activities in Kenya The contractor shall travel to the four sites to close out the monitoring activities. To accomplish this task, the contractor shall:

a. Assure that all data collection forms for each site have been adequately and accurately completed;

b. Assure that all data collection forms for each participant have been completed;

c. Review the status of all outstanding data forms and the timeline for their resolution;

d. Assure that a progress note is included in each participant’s medical record indicating that study participation has ended;

e. Confirm that pertinent IRBs have been informed that the study has closed;

f. Verify that all regulatory and other pertinent documents are current and on file;

g. Verify that the investigators and study coordinator have prepared and are following study termination instructions as proposed in the protocol;

h. Ensure that the PI understands the requirements for reporting adverse events for participants who have completed the study and the requirements for retention of study records; and

i. Review plans for electronic data storage, retrieval and access (including but not limited to issues of privacy, security, and confidentiality).

Reporting requirements

Within two weeks of the close of each close-out monitoring site visit, the contractor shall provide an electronic copy of the draft site visit report to the CDC COTR. The report shall include specific recommendations based on a review of all study documents and findings. The report shall be written in Microsoft Word (latest version).

CDC shall review the draft report and provide comments and recommendations to the contractor within one week of receipt. Within four weeks following all close-out site visits, the contractor shall provide an electronic copy of the final comprehensive site visit report to the Contracting Officer and the COTR.

Deliverables

Table 3 Task #3 Deliverables

Period of Performance:

Eighteen months from date of award of the task order

Performance-Based Matrix

Surveillance "Incentives" Positive or Negative

and observation.

Past Performance and Evaluation to Determine whether or not to Exercise Future Options.

and observation.

Past Performance and Evaluation to Determine whether or not to Exercise Future Options.

PAGE

[1]