Statement of Work 1228943.pdf

Web Based Training System for FDA

ID: 1228943

Statement of Work (SOW)

Project: Contractor shall provide Web-Based Training System for FDA Personnel in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, and Good Clinical Practice.

GENERAL INFORMATION

1. Background: The Food and Drug Administration (FDA) is responsible for ensuring that Human Subjects Research (HSR)complies with Federal regulations. FDA is mandated by federal regulations to give its employees the opportunity to acquire the skills and competencies necessary to carry out its mission. FDA must provide the required trainings for FDA researchers in the areas of Human Subjects Research, Responsible Conduct of Research, Animal Care and Use, and Good Clinical Practice, and, the general research ethics compliance.

These trainings are mandated by the following Federal regulations:

The regulations at Code of Federal Regulations (CFR) Title 45, Part 46, Federal Policy for the Protection of Human Subjects (with Subpart A known as the “Common Rule”), describe requirements for research involving human subjects conducted, supported or otherwise subject to regulation by the U.S. Department of Health and Human Services, and accordingly for research involving human subjects conducted or supported by FDA.

The FDA, including the FDA Institutional Review Board (IRB), will comply with 45 CFR Part 46 and FDA standard operating procedures (SOPs) regarding human subjects’ research conducted or supported by the FDA. In addition, such research and the FDA IRB must comply with FDA regulations (such as 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812), as applicable, and should generally follow applicable FDA and Office for Human Research Protections (OHRP) guidance documents.

The contractor shall provide web-based trainings in the areas of research ethics, compliance, and best practices education, in all mandated areas. The trainings should be accessible to FDA employee in various geographic sites to meet the training needs of FDA researchers in FDA’s various geographic area.

2. Objectives: The objective of the Project, entitled “Web Based Training System for FDA Personnel in the areas of Human Subjects Research Protection, Responsible Conduct of Research, Animal Care and Use, and, Good Clinical Practice” is for contractor to provide mandated research ethics/compliance training to FDA authorized personnel (referred to herein as FDA learners) as required to support FDA’s responsibilities including oversight and monitoring functions for research protections in FDA supported and regulated research.

3. Scope of Work: Contractor shall develop and provide web-based educational program in research ethics and compliance. The education program shall be available to FDA personnel with 24/7 online access. The web-based training program shall contain subject matter content specifically addressing Human Subjects Research (“HSR”) ethics requirements under applicable Federal regulations, as well as Responsible Conduct of Research (RCR), Animal Care and Use (ACU), and Good Clinical Practice (GCP).

a. Target audience

FDA employees, investigators, fellows, and students conducting research at the FDA

4. 508 Standard Requirements

Contractor shall provide web-based training courses according to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) that requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards (http://www.section508.gov/). This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs that is comparable to that provided to individuals without disabilities, unless an undue burden would be imposed on the agency.

5. Tasks:

Web-based training Courses .

• Human Subjects Research: Contractor shall provide two tracks of human subjects protection training to FDA learners. The two tracks of human subjects protections training are:

- Track 1: Social/Behavioral/Educational Research (SBER)

- Track 2: Biomedical Research (BIOMED)

• Responsible Conduct of Research: Contractor shall provide RCR training to FDA learners via on or more learner group(s) (courses(s)) defined by the FDA.

• Animal Care and Use: Contractor shall provide ACU training to FDA learners via a learner groups (courses) defined by the FDA.

• Good Clinical Practice: Contractor shall provide GCP training to FDA learners via a learner group(s) (courses(s)) defined by the FDA.

• Refresher Courses: Contractor shall provide HSR "refresher"/ "recertification" courses for FDA learners as part of the above content categories.

http://www.section508.gov/

• The contractor shall integrate updates and new modules as needed into training course materials for FDA learners. The contractor shall provide notification to the FDA as changes/revisions/updates are made.

• Assessments.

The contractor shall provide a learning assessment (quiz) at the end of each course module. The quiz shall be designed to assess each learner’s understanding of the key issues in the course module. The quiz questions shall be based on the stated learning objectives and constructed to be an assessment as well as a learning tool. Feedback provided to each learner after the quiz shall informs the learner as to why the answer provided was correct or incorrect. The contractor shall provide the FDA learner the opportunity to return to the module, re-read the module content, and retake the quiz to obtain a higher score.

• Certificates of Completion/Transcript.

The contractor shall provide permanent links to Completion Reports and Completion Certificates to each learner following their course completions via an automatically-generated email. If a passing grade is not obtained by the learner, the learner shall be instructed to repeat the course. Completion Reports also should contain transcript information that details the modules completed by the learner and the quiz score for the respective modules at the time of course completion. Completion Certificates shall be provided to learners.

• Training Database and Reporting.

The contractor shall provide tracking and management of completed training of FDA learners.

▪ The training database shall retain training results as either a "Complete" or "Incomplete”. FDA personnel with administrator access to the training program shall be able to query the training database for specific learner information as well as download reports as necessary.

▪ The training database shall have a Help Desk to provide customized automated usage reports (for import into other tracking systems) that include cumulative or incremental details on those FDA personnel completing of courses.

• FDA learner comments/questions.

Each FDA learner shall have the opportunity at the end of each course/module to send a comment or question to the training program administrator about a specific issue or problem. FDA learners shall also be able to contact the Help Desk directly by email at any time and by phone during office hours.

• Task and Help Desk Services.

The contractor shall provide a Help Desk functionality, during normal working hours (8:30 am to 7:30 pm U.S. Eastern Time, Monday through Friday except for holidays).

- FDA learners can contact the Help Desk directly by email at any time and by phone during the listed Help Desk hours.

- The Help Desk shall work with designated FDA administrators to:

▪ Integrate new modules, courses, and learner groups into training course materials as needed.

▪ Provide FDA administrators with functionality for ad hoc queries of the training program user database to evaluate the training progress of any FDA learner.

▪ Customize access for FDA personnel according to role or interest in research and research ethics area.

• Ongoing Support.

The contractor shall make the learning experience as easy as possible for FDA learners and for FDA administrators. For example, contractor should:

• Be available for coordination/meetings with the FDA regarding updates to current modules and development of future work (e.g., content modules, data collection methods, learner groups).

• Be available for coordination/meetings with the designated FDA administrators regarding updates to current modules and development of future work (e.g., content modules, data collection methods, learner groups).

• Be available for affiliated FDA learners to address questions and problems, by Help Desk services.

• Notify each FDA learner when new courses become available

• Notify the applicable FDA learner when training certificates for previously-completed courses will expire and re certification training is due.

• Other courses

In addition to the courses listed above, the contractor shall offer at no additional fee, unlimited access for FDA personnel to the following basic course modules, cases, and quizzes for:

• Conflicts of Interest course.

• Information Privacy and Security course

The table below describes the task requirements of this contract along with the deliverables:

Task Deliverable

All web-based trainings courses ( see above)

Upon deployment of the contract

Contractor Requirements

Contractor Personnel:

Functional Responsibility:

The contractor shall provide all personnel, technology, and supervision necessary to provide the specified training services to the FDA employee, in accordance with the Statement of Work and all terms and conditions of this contract.

Minimum Education and Experience Requirements:

The contractor shall provide experienced and knowledgeable personnel who have successfully performed similar work as those described in the respective SOW. The contractor shall provide adequate supporting documentation regarding personnel qualifications to the COTR for review in the form of resumes, CV’s, or other similar documentation that demonstrates requisite training and experience. Any remaining concerns regarding the qualifications of Contractor personnel shall be submitted to the Contracting Officer for resolution.

All proposed Contractor personnel shall have the experience and training necessary to perform the services of an expert. FDA shall not incur training expenses or billable hours to bring personnel up to requisite levels of expertise