Current Issues in China Clinical Trial Patient Recruitment and Retention

China Trial Recruitment Sept 2011 from yinglu

Clinical Research Management SOP Usage Survey

Clinical Research SOP usage Survey from Ying Lu

EMR – Where Do I Chart That?

This course is provided by Center for Professional Practice of Nursing at UC Davis Medical Center. It designed to assist the bedside nurse revisit where to chart that important information. Focus will be hands-on of the where, what and why of EMR documentation. Although this class is designed to assist nurses in updating their documentation skills, review changes, tips and shortcuts for successful real time documentation, it could be beneficial for research coordinators who use EMR to extrating clinical data, ordering lab tests, monitoring adverse envets, and etc. EMR – Where Do I Chart That?

UC Davis Clinical and Translational Science Center (CTSC)

UC Davis Meical Center CTSC is one of the first 12 institutions of the Clinical and Translational Science Awards program that received a 5-year $25 million grant from NIH. It provides clinical trial education training programs and services for supporting clinical and translational research and industry sponsored clinical trials for FDA applications.
Clinical Trials Resource Group: For Investigators
CTSC 2012 Clinical Research Education Calendar

FDA Posted Recently Updated Guidance Documents (Feb., 2012)

Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements,21 CFR § 50.25(c) (Small Entity Compliance Guide)

Guidance for IRBs,Clinical Investigators,and Sponsors: IRB Continuing Review After Clinical Investigation Approval

Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, Final Guidance

Organ Transplants Without Life-Long Immunosuppresant Drugs

March 19, 2012 NIH Research Matters reported an ongoing clinical trial showed transplant recipients had achieved long-lasting chimerism with donor's immune cells transfused one month after renal transplant surgery. Five of 8 patients are immunosuppresant drug free with none signs of graft-versus-host disease.

FDA Issues Guidance on Acceptance of Foreign Studies Not Conducted Under an IND

FDA has issued the guidance, "FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions."  This guidance document is intended to clarify for sponsors and applicants how they can demonstrate compliance with the requirements of 21 CFR 312.120.  It provides recommendations for the submission of information, whether in an IND or application for marketing approval for a drug or biological drug product, to demonstrate that a non-IND foreign clinical study was conducted in accordance with GCP.

FDA Informed Consent Elements Update (21 CFR 50.25c, Feb., 2012)

For applicable clinical trials initiated on or after March 7, 2012, informed consent documents must be in compliance with the new requirement in 21 CFR § 50.25(c) and include a specific statement that refers to the trial’s description on www.ClinicalTrials.gov.

Under new 21 CFR 50.25(c), the following statement must be reproduced word-for-word in informed consent documents for applicable clinical trials. IRBs cannot modify or delete the exact statement regarding www.ClinicalTrials.gov as stated in 21 CFR § 50.25(c).

“A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

An “applicable clinical device trial”:
(I) the trial prospectively compares a device-based intervention subject to FDA regulation against a control in human subjects; or (II) the trial is a pediatric post-market surveillance trial. 42 U.S.C. § 282(j)(1)(A)(ii).

An “applicable clinical drug trial”:
The trial is a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to FDA regulation. 42 U.S.C. § 282(j)(1)(A)(iii)(I).

Clinical trials are specifically excluded from the definition of “applicable clinical trials”:
For devices, small feasibility trials and larger clinical trials of prototype devices with a primary measure of feasibility rather than health outcomes are not applicable clinical trials. 42 U.S.C. § 282(j)(1)(A)(ii). Under current guidance contained on NIH’s website at http://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf, a device trial is not an applicable device clinical trial when the trial includes only de-identified human specimens and does not include “human subjects” (a requirement to be considered an applicable clinical trial).

For drugs, phase 1 clinical investigations (defined in 21 C.F.R. § 312.21) are not categorized as “applicable clinical trials.” 42 U.S.C. § 282(j)(1)(A)(iii). Uncontrolled clinical investigations of drugs or devices also are not considered “applicable clinical trials.”

Original document can be found from the link below:
Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c), Fab., 2012

FDA 21 CFR Covers Primary Regulations for Conducting of Investigational Device Exemptions Medical Device Clinical Studies

21 CFR 812, Investigational Device Exemptions (IDE)

It covers the procedures for the conduct of clinical studies, application, responsibilities of sponsors and investigators, medical device labeling, records, and reports.

21 CFR 820 SubpartC, Design Controls of the Quality System Regulation

It provides the requirement for procedures to control the design of the device.

21 CFR 50, Protection of Human Subjects

It provides the requirements and general elements of informed consent.

21 CFR 56, Institutional Review Boards

It covers the procedures and responsibilities for an IRB that approves clinical investigations protocols.

21 CFR 54, Financial Disclosure by Clinical Investigators

It covers the disclosure of financial compensation to clinical investigators that are part of the FDA’s assessment of the reliability of the clinical data.

Clinical Study with Medical Devices

A significant risk device study, a sponsor must:
Clinical studies with medical devices that pose a significant risk require both FDA and an Institutional Review Board (IRB) approval prior to initiation of a clinical study. FDA approval is obtained by submitting an IDE application to FDA (§812.20).

• Submit a complete IDE application  (§812.20) to FDA for review and obtain FDA approval of the IDE; submit the investigational plan and report of prior investigations(§812.25 and §812.27) to the IRB at each institution where the investigation is to be conducted for review and approval; and

• Select qualified investigators, provide them with all necessary information on the investigational plan and report of prior investigations, and obtain signed investigator agreements from them.

An IDE application is considered approved 30 days after it has been received by FDA, unless FDA otherwise informs the sponsor prior to 30 calendar days from the date of receipt, that the IDE is approved, approved with conditions, or disapproved. 

Nonsignificant Risk Device
Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catheters.

• A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving nonsignificant risk devices are not required to submit an IDE application to FDA for approval.

IDE Exempt Investigations
All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation. Investigations that are exempted from 21 CFR 812 are described in §812.2(c) of the IDE regulation. Studies exempt from the IDE regulation include

• a legally marketed device when used in accordance with its labeling
• a diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing:
• is noninvasive;
• oes not require an invasive sampling procedure that presents significant risk;
• does not by design or intention introduce energy into a subject; and
• is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure; "Regulating In Vitro Diagnostic Device (IVD) Studies."

• consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) with an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk;

• a device intended solely for veterinary use;

•  a device shipped solely for research with laboratory animals and contains the labeling "CAUTION – Device for investigational use in laboratory animals or other tests that do not involve human subjects."

Depending upon the nature of the investigation, those studies which are exempt from the requirements of the IDE regulation may or may not be exempt from the requirements for IRB review and approval under Part 56 and the requirements for obtaining informed consent under Part 50.