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Checklists can be very effective in investigating compliance trends across sites, or in identifying sites that may require the rigor of an audit. CIS has developed two checklists, click on the links to download.
Checklist #1: GCP Compliance Checklist: Sponsor/CRO Systems
Checklist #2: GCP Compliance Checklist: Specific Clinical Trial

The TRICARE Final Rule was enacted by the Department of Defense on March 17, 2009.  Recent challenges to the rule, which mandated that manufacturers refund amounts in excess of the Federal Ceiling Price (FCP),  led to a surprising turn of events. Listen to this 10-minute podcast for background and recent changes to the TRICARE Final Rule.

The Pharma Compliance Blog, created and run by Compliance Implementation Services, is a completely free gathering place in which members of the pharmaceutical industry can exchange information and discuss issues in a safe environment. The site, www.pharmacomplianceblog.com, features daily posts and articles, key industry terms and the most recent pharmaceutical news. The blog also archives all previous posts and relevant comments so that visitors can tour the site for key issues related to their department and overall business. 

Pharma Compliance Exchange (PCX) The best sources for critical compliance information – Clinical R&D: http://clinical.cis-pcx.com, Sales & Marketing: http://sales.cis-pcx.com and Government Programs: http://gp.cis-pcx.com

The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation.
http://www.fda.gov

The International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration. http://www.ich.org/cache/compo/276-254-1.html

The European Commission (formerly the Commission of the European Communities) is the executive branch of the European Union. The body is responsible for proposing legislation, implementing decisions, upholding the Union's treaties and the general day-to-day running of the Union.
http://ec.europa.eu/index_en.htm

Centers for Medicare and Medicaid Services (CMS) is an agency within the Department of Health and Human Services, is responsible for administering the Medicare and Medicaid Programs. As such, CMS issues rules and guidance pertaining to both Programs. For an exhaustive listing of CMS information, please refer to this site:
 www.cms.hhs.gov.

HHS-Office of Inspector General (OIG) is responsible for investigating fraud, waste, and abuse among the various Federal health care programs. The OIG has issued both program-specific and general compliance-related regulations and guidance. For an exhaustive listing of OIG information, please refer to this site:
 www.oig.hhs.gov.

HRSA Office of Pharmacy Affairs (OPA) is an Office within the Health Resources and Services Administration, an agency within the Department of Health and Human Services. The OPA is responsible for administering the 340B Program, which provides discounted drug pricing to certain statutorily defined entities. The OPA works in conjunction with the Pharmacy Services Support Center (PSSC) as well. All three organizations, including the Public Health Service, have issued regulations and/or guidance pertaining to the 340B Program. For an exhaustive listing of HRSA, OPA, and PSSC information, please refer to these sites:
http://www.hrsa.gov/, http://www.hrsa.gov/opa/, http://pssc.aphanet.org/.

Department of Veterans Affairs (VA) is responsible for overseeing and administering many different veterans' benefits, only one of which pertains to drug pricing. The VA has issued regulations and guidance pertaining to the VA drug pricing. For an comprehensive listing of VA information, please refer to this site:
http://www.va.gov/.

TRICARE Management Authority (TMA) and the Department of Defense are responsible for administering TRICARE, a program which is part of the CHAMPUS Program. Both organizations have issued regulations and guidance pertaining to the TRICARE Program. For an comprehensive listing TRICARE information, please refer to the following sites:
 http://www.tricare.mil/ and http://www.defenselink.mil/.
 Listen to this industry attended teleconference to hear more about TRICARE.