You may find the following resources helpful in initiating and managing your clinical research study, especially if you are conducting a multi-center study.   Multi-center studies require additional administrative oversight and can benefit from standardization of consent forms and adverse event reports or obtaining agreement on publication policies or data dissemination.   

Application Submission Tools

PHS 398 application forms

SF 424 electronic application forms

NIAID's Annotated R01 Grant Application and Summary Statement provides an example of a well written basic science application which may be helpful to applicants writing clinical research applications as well.

An Evidence-Based Guide to Writing Grant Proposals for Clinical Research. 
Inouye SK, and Fiellin DA. Ann Intern Med. 2005 Feb 15;142(4):274-82.

NIAID’s “NIH Grant Cycle: Application to Renewal”

Consent Form Tools

The Office of Biotechnology Activities has prepared NIH Guidance on Informed Consent for Gene Transfer Research.

Informed Consent Checklist describes required and additional elements in consent forms by OHRP

Informed Consent Tools from Clinical Trials Networks Best Practices: NIH Roadmap provides checklists and templates for consents, parental permissions and witnesses.

The Center for Health Studies Readability Toolkit was created to help research teams develop study materials that participants can easily read and understand in “plain language,” that describes exactly what the reader needs to know without using unnecessary or overly complex words.

Templates

Conflict of Interest Disclosure for Investigators involved in a study

Consent Form Template - will assist you in creating a consent form for a clinical research study. It is important that you check with your local IRB to see if they have their own requirements for a particular format. The Code of Federal Regulations requires that certain elements be contained in the form. This template includes those basic elements and several others that may enhance the study participant's understanding of the research.

Consent Template for Cancer Treatment Trials by NCI

Data Monitoring Plan Checklist

DSMB Charter

Evaluation Tool to assess Clinical Sites

Evaluation Tool to assess a Data Coordinating Center

Manual of Operations for Policies and Procedures in a multi-center study or Network

Protocol Template - will assist you in developing a protocol for a clinical study. Information can be easily deleted or added to the document. When changing information, the user will need to go back to the Table of Contents, right click anywhere on the Table and choose “Update Field” in order for the document to readjust the outline numbers and to renumber the pages.

Additional Toolkit Resources

Clinical Trials Networks Best Practices: NIH Roadmap offers some additional resources to aid investigators in the conduct of their studies.

Human Subjects Protection

Many institutions have a training program for research personnel conducting research at their institution. The NIH Office of Extramural Research (OER) provides a free tutorial, web-based course called Protecting Human Research Participants that satisfies the human subjects training requirement for obtaining NIH awards and the NIH provides researchers with Computer Based Training on protecting human subjects. Once either course is completed, a certificate can be printed for inclusion in your grant file.

"Investigator 101" is a CD ROM available from OHRP to institutions that have a Federal wide Assurance (FWA) or a Multiple Project Assurance (MPA). The CD-ROM was produced by the Public Responsibility in Medicine and Research (PRIM&R) and has been professionally produced and edited to provide education on the responsible conduct of human research and protection of human subjects. It is a remarkable educational tool that provides a combination of interactive features such as, speaker slide presentations, transcripts, ethical and research guidelines, and federal regulatory documents. Contact your organization to review the CD or you may order a copy from OHRP. Ordering information is found here at the following link: http://www.hhs.gov/ohrp/references/cdrom.pdf

Good Clinical Practice

Good Clinical Practice is a set of rules and regulations that is provided by International Conference on Harmonisation - an international body that regulates clinical trials involving human subjects. The guidelines discuss protection of human rights as a subject in a clinical trial and provide guidance on how clinical trials should be conducted.

Good Clinical Practice in FDA-Regulated Clinical Trials

PharmaSchool GCP Challenges offers brief quizzes to assess your knowledge on a number of GCP related topics such as Informed Consent and Adverse Events.

Clinical Research Training Opportunities

CC-Duke Training Program in Clinical Research leads to a Master of Health Sciences in Clinical Research, a professional degree awarded by the Duke University School of Medicine. There is also a non-degree option for qualified students who want to pursue specific areas of interest.

Society of Clinical Research Associates Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals.

The Society for Clinical Data Management is a non-profit, professional society founded to advance the discipline of Clinical Data Management. The binding interest of all members is quality clinical data management practices.

The Society for Clinical Trials is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies.

Public Responsibility in Medicine and Research (PRIM&R) is dedicated to creating, implementing, and advancing the highest ethical standards in the conduct of research.

Association of Clinical Research Professionals (ACRP) is the primary resource for clinical research professionals in the pharmaceutical, biotechnology, and medical device industries, as well as those in hospital, academic medical centers, and physician office settings.