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 Training Topic : Biostatistics (1)
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| Introduction to Biostatistics | Introduction to Biostatistics provides an introduction to selected important topics in biostatistical concepts and reasoning through lectures, exercises, and bulletin board discussions. This course represents an introduction to the field and provides a survey of data and data types. Specific topics include tools for describing central tendency and variability
in data; methods for performing inference on population means and proportions via sample data; statistical hypothesis testing and its application to group comparisons; issues of power and sample size in study designs; and random sample and other study types. While there are some formulae and computational elements to the course, the emphasis is on interpretation and concepts.
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| Training Topic : Community (2)
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| Research Ethics Training Curriculum for Community Representatives | FHI's Office of International Research Ethics (OIRE) has developed a dynamic and innovative curriculum to empower community representatives through training and education to act as a competent voice for research participants worldwide. Developed and field-tested in eight countries, the Research Ethics Training Curriculum for Community Representatives (RETC-CR) helps community representatives to understand the research process and their roles and responsibilities as partners of the research team. The Curriculum also explains the corresponding roles and responsibilities of Ethics Committees/IRBs and Researchers. The RETC-CR addresses universal principles of research ethics, informed consent, ethics committees and other important issues. The RETC-CR was recipient of The 2005 Distinguished Award of the Society for Technical Communication. |
| Understanding the clinical research process and principles of clinical research and The role of a CAB and principles of community involvement | The Community Partners Training Working Group (CTWG) created a set of standardized, high quality CAB training materials for cross-network use. Community Partners (CP) agreed on a selection of specific cross-network training topics as priorities and reviewed the existing training materials to develop a cross-network trainer’s guide and training module on the topics of Understanding the clinical research process and principles of clinical research and The role of a CAB and principles of community involvement. |
| Training Topic : DAIDS Policy (1)
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| DAIDS Policy Training |
Training on DAIDS policies can be completed as follows: Unless otherwise indicated by DAIDS, trainees can meet these requirements by reading and signing off on each policy.
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| Training Topic : DAIDS-ES Applications (3)
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| Clinical Site Monitoring (CSM) | Clinical Site Monitoring provides DAIDS with a unified system that serves as the official information source for clinical site monitoring activities. It is used by DAIDS personnel and collaborators involved in monitoring DAIDS clinical trials. Its tools, which are on the new paradigm for CSM set forth by DAIDS, were implemented to enhance and improve the scheduling, conduct, and reporting of information related to clinical site monitoring visits. Specifically, the tools are designed to identify and track monitoring visit schedules and assignment requests, and help resolve issues identified during site visits. |
| DAIDS Adverse Experience Reporting System (DAERS) | DAERS enables DAIDS and its collaborators to report Expedited Adverse Events (EAEs) effectively, in accordance with the safety reporting guidelines set forth by DAIDS, FDA and ICH in the conduct of human subject clinical trials. DAERS is a Web-based system that supports real-time reporting of and access to EAEs. This component ensures accuracy of its data capture by using built-in data validation checks and lists of values. It is designed to support therapeutic, vaccine, and prevention EAE reporting. |
| DAIDS Protocol Registration System (DPRS) | The DPRS provides DAIDS with a unified centralized system that will serve as the official information source for Protocol Registration activities involving registering a Clinical Research Site (CRS) to a protocol. DPRS provides the CRSs tools to electronically submit protocol registration documents to the DAIDS Protocol Registration Office (PRO), track and monitor progress of their submission, provide corrections, and respond to materials, receipt alerts, reminders and notifications. DPRS also provides Web services to DAIDS collaborators for interacting with the system and receive Protocol Registration information. |
| Training Topic : Ethics (8)
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| Basic health research ethics course |
The African Malaria Network Trust offers a free web-based basic Good Clinical Practice course. This course is primarily created for young to middle level researchers and physicians interested in clinical research with a bias to product development.
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| Clinical Trials Networks Best Practices - Education |
This website provides several different resources that offer trainings to those in the research field.
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| Ethical and regulatory aspects of clinical research |
Free courses offered to anyone interested in or involved in clinical research involving human subjects.
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| Fogarty International Center (FIC) - International Research Ethics Resources | The folllowing webpages are intended to provide a compliation of ethics resources for researchers, IRB members, teachers, students and anyone else involved in clinical research outside the US. |
| HPTN Ethics Guidance for Research |
Revised ethics guidance based on findings over the past several years in HIV research.
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| Research Ethics Training Curriculum | This curriculum is for international scientists who conduct research that includes human participants and who want to incorporate fundamental ethical considerations in the design and implementation of their studies.
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| Responsible Conduct of Research |
CITI has provided access to 2 courses in the Responsible Conduct of Research. One is focused on biomedical research and the second is focused on social and behavioral research.
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| Training in the Responsible Conduct of Research |
This site provides resources to several different ethical courses offerred from a variety of institutions.
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| Training Topic : GCP (4)
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| Africa Malaria Network GCP |
The African Malaria Network Trust offers a free web-based basic Good Clinical Practice course. This course is primarily created for young to middle level researchers and physicians interested in clinical research with a bias to product development.
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| CITI GCP Training | Free Good Clinical Practice training is available through the Collaborative Institutional Training Initiative (CITI) to the staff of DAIDS-sponsored clinical research network core operations centers and research sites. This course is currently available in English, Spanish, Portuguese, Thai, Chinese, Korean and French. |
| NIAID GCP Training |
The NIAID Learning Center is one training resource available to DAIDS grantees and DAIDS staff. Completion of all 4 modules in the GCP Learning Center addresses the content requirements for HSP, GCP and FDA elements found in the DAIDS Policy "Requirements for Human Subject Protection and Good Clinical Practice Training for Clinical Research Site Personnel". Note: These modules do not cover the requirements for training on DAIDS Policies.
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| Training in Tropical Diseases GCP |
These courses include a GCP workshop for potential monitors, annual GCP refresher courses for monitors, a GCP workshop for investigators and a GCP workshop for potential auditors
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| Training Topic : Grants Policy and Management (2)
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| All About Grants |
'All About Grants' helps investigators plan and write grant applications and manage their awards. Advice comes from the knowledge and views of NIAID staff, including former NIH grantees.
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| NIH Grants Policy and Management Training |
This course teaches foreign grantees, investigators, and project leaders how to manage NIH grant funds and comply with requirements.
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| Training Topic : HSP (3)
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| CITI HSP Training | Free Human Subjects Protection training is available through the Collaborative Institutional Training Initiative (CITI) to the staff of DAIDS-sponsored clinical research network core operations centers and research sites. This course is also available as a refresher course through CITI. Each course is also available in Spanish and Portuguese. |
| NIAID Learning Center Training |
The NIAID Learning Center is one training resource available to DAIDS grantees and DAIDS staff. Completion of all 4 modules in the GCP Learning Center addresses the content requirements for HSP, GCP and FDA elements found in the DAIDS Policy "Requirements for Human Subject Protection and Good Clinical Practice Training for Clinical Research Site Personnel". Note: These modules do not cover the requirements for training on DAIDS Policies.
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| OER HSP Training |
Protecting Human Research Participants (PHRP) - On-line tutorial. The OER tutorial is a free, web-based course that presents information about protections for human participants in research. The tutorial is designed for those involved in the design and/or conduct of research involving human participants. It satisfies the NIH human subjects training requirement for obtaining NIH awards, but it is not the only way to satisfy this requirement.
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| Training Topic : Laboratory (1)
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| Good Clinical Laboratory Practice (GCLP) Online Refresher Course |
This GCLP online refresher course consists of 10 modules. Each module takes about 1 hour to complete. This course is accessible through the DAIDS Learning Management System (DLMS).
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| Training Topic : Miscellaneous (3)
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| NIH Videocasting and Poscasting |
The Center for Information Technology (CIT) at the NIH can broadcast your seminar, conference or meeting live to a world-wide audience over the Internet as a real-time streaming video. The event can be recorded and made available for viewers to watch at their convenience as an on-demand video or a downloadable podcast. CIT can also broadcast NIH-only or HHS-only content.
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| NIH4Health Channel |
YouTube hosts a dedicated channel streaming a variety of topics discussed by health experts around the world.
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| OHRP Educational Videos | OHRP is pleased to announce the availability for the first time of
educational videos on the HHS YouTube channel. The videos are
accessible through the OHRP playlist and include
"Research Use of Human Biological Specimens and Other Private
Information" and "Reviewing and Reporting Unanticipated Problems and
Adverse Events," (both of which premiered and are still available also
in RealPlayer format), in addition to two new videos "Institutional
Review Board (IRB) Membership" and "General Informed Consent
Requirements Parts I (Research Investigator)and II (Research Subject)."
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| Training Topic : Protocol Registration (1)
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| Protocol Registration | This session includes training on the DAIDS Protocol Registration Policy and Manual. This does not include training on the web-based DAIDS Protocol Registration System (DPRS).
The PR live webinar training session will elucidate current PR requirements as described in the new PR Policy and Manual.
The deadline for compliance with the new Policy and Manual is November 01, 2010.
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| Training Topic : Quality Management (1)
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| DAIDS Quality Management | This training is comprised of three sessions that are designed to build off from one another to provide a comprehensive learning experience. |
| Training Topic : Safety Training Resources (1)
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| Safety Training Resources | The DAIDS Regulatory Support Center (RSC) provides a comprehensive overview on all Safety Trainiing Resources provided from DAIDS which include powerpoints on: Safety Workshop Basic Principles, Safety Workshop EAE Module, EAE Core Slide Set, and the DAERS Training Slide Set. |