archive-us.com » US » D » DCRC.US

Total: 18

Choose link from "Titles, links and description words view":

Or switch to "Titles and links view".
  • Detroit Clinical Research Center - IRB
    Join our Team Contact us Contact DCRC Home Our Services IRB For multi site studies a central IRB is permitted under the oversight of local IRB s A parallel process of central and local IRB s is initiated per the client s request Most principal investigators are independent professional corporations that accept central IRB approvals However if the study requires the use of a hospital for services a local IRB

    Original URL path: http://www.dcrc.us/pages/irb.html (2016-04-25)
    Open archived version from archive


  • Detroit Clinical Research Center - Lab Services
    outpatient service centers DCRC may also work with central labs suggested by sponsors The laboratory staff is comprised of highly experienced scientists committed to quality accessibility and cost effectiveness The laboratory network supports all types of needed lab work and could transport samples from remote sites to main hospitals The pathology staff includes board certified physicians in anatomic and clinical pathology as well as subspecialty certified in cytopathology immunopathology chemical

    Original URL path: http://www.dcrc.us/pages/lab-services.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Data Management
    in the success accuracy and safety of data Therefore we employ advanced tools led by staff with extensive experience in data management Our data management services include Database design Forms management Web interface and Graphical User Interface GUI for each study per the sponsor s requirement Database programming Medical coding Case report form design electronic and paper versions Data entry and status reporting We support most commercial Electronic Data Capture

    Original URL path: http://www.dcrc.us/pages/data-management.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Regulatory Services
    Team Contact us Contact DCRC Home Our Services Regulatory Services DCRC provides regulatory services to sponsors and institutions in several regulatory areas Regulatory consultation on FDA GCP HIPPA compliance Informed Consent design protocol writing Preparation and Filing of Investigators initiated IND IDEs Safety reporting to regulatory bodies Clinical study reports DCRC also prepares submits tracks and maintains clinical trial applications to the regulatory authorities and reviews the clinical trial documentation

    Original URL path: http://www.dcrc.us/pages/regulatory-services.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Feasibility Studies
    Team Contact us Contact DCRC Home Our Services Feasibility Studies With vast experience in hundreds of clinical studies DCRC s multi disciplinary staff will bring excellent insight to our sponsors studies Launching a feasibility study is an excellent step towards the success of a larger study We encourage our sponsors to contact us to assist them in developing feasibility studies including all aspects of patient recruitment inclusion and exclusion criteria

    Original URL path: http://www.dcrc.us/pages/feasibility-studies.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Volunteer information
    clinical research study is conducted by qualified doctors to evaluate a new investigational treatment for a certain illness Before any investigational treatment is given to subjects in a clinical research study it is researched in a laboratory Clinical research studies provide a way to test experimental treatments Every widespread treatment today has been proven safe and effective in a clinical trial Each study is designed for a particular group of people whose ability to participate in the trial is based on a detailed set of criteria These criteria include age health disease history and lifestyle factors Adults with a clean bill of health may be subject in healthy volunteer trials while people with existing medical conditions may be subjects for patient trials When enrolling in a study Volunteers will be counseled with regards to the requirements and expectations related to a specific study including the benefits and risks of study participation Our staff maintains relationships with community based physicians and local health advocacy organizations and we often provide our patients with support information educational material and referral services If you wish to participate in a study you will be greeted by a clinical research coordinator who will ask you a

    Original URL path: http://www.dcrc.us/pages/volunteers-info.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Investigator FAQ
    your authorization must be submitted to the IRB for review and be approved prior to its use What is Quality Assurance in research There is a system of checks and balances in place for the conduct of clinical research Regulations and guidelines make up part of this system Quality assurance QA professionals use these tools as they conduct audits to assess compliance with Good Clinical Practice GCP What protocol deviations or violations are required to be reported Protocol deviations or violations that either increase the risk to subjects or affect the integrity of the study data must be reported to the IRB IRBs deem any deviation violation from the protocol that increases the risk to subjects or affects the integrity of the study data to be significant An isolated issue may not be significant by itself but significance may increase with numerous deviations of the same nature Significant deviations may be events such as enrollment of subjects who did not meet inclusion exclusion criteria use of the wrong informed consent document or failure to perform appropriate procedures at a study visit Submissions should be made on the IRB s Protocol Deviation Report Form and Investigators should submit information to the IRB within 10 working days after becoming aware of a significant protocol deviation What are the responsibilities of the Principal Investigator The principal investigator is responsible for personally conducting or supervising the conduct of human subjects research and for protecting the rights safety and welfare of the subjects enrolled in the research The PI must ensure that all human subjects research is conducted in an ethical manner and in accordance with all federal state and local laws and regulations institutional policies and requirements Ensuring that the research protocol has sound design minimizing risks to subjects while maximizing research benefits Protecting

    Original URL path: http://www.dcrc.us/pages/investigator-faq.html (2016-04-25)
    Open archived version from archive

  • Detroit Clinical Research Center - Investigator Enrollment
    staff for a detailed discussion Clinical trials are conducted to allow safety and efficacy data to be collected for new drugs or devices These trials can only take place once satisfactory information has been gathered on the quality of the product and its non clinical safety and Health Authority Ethics Committee approval is granted in the country where the trial is taking place Depending on the type of product and the stage of its development clinical trials enroll healthy volunteers and or patients into small studies initially followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment As positive safety data is gathered the number of patients can be increased Clinical trials can vary in size from a single centre in a single country to multi centers in multiple countries Physician Requirements include ICH GCP Training Human Participant Protections Education Willingness to sign a contract Willingness to comply and participate in the clinical trial until close out Previous research experience preferred Responsibility for the safety of the subjects in a clinical trial is shared between the sponsor the local site investigators if different from the sponsor the various IRBs that supervise the study and in some cases if the study involves a marketable drug or device the regulatory agency for the country where the drug or device will be sold A physician s first duty is to his her patients and if a physician investigator believes that the study treatment may be harming subjects in the study the investigator can stop participating at any time On the other hand investigators often have a financial interest in recruiting subjects and can act unethically in order to obtain and maintain their participation The investigators are responsible for conducting the study according to the study

    Original URL path: http://www.dcrc.us/pages/investigator-enrollment.html (2016-04-25)
    Open archived version from archive



  •