An investigator, An auditor has access to ALL records, including. DATA MANAGEMENT. - Coding Dictionary Use/Abuse. - The Importance of Standard Operating Procedures (SOPs) in Clinical Trials Final Draft CTN108: SOPs 11/30/09 * If the sponsor has not defined the imaging parameters ... - The contents of this presentation are my own, and do not necessarily reflect the ... IRB or Human Subject Protections Marian Serge, 301-796-5644 ... INTRODUCTION TO GOOD CLINICAL PRACTICE GCP IN RESEARCH. Title: Are We Ready for an Audit and Inspection as a Sponsor? IRB rules. - ... Each site sends data to the QACT data repository * Promptly Report Adverse Events to ... Friedman et al. - RTRN Good Clinical Practice Series Coordinated ... www.ich.org www.fda.gov www.nih.gov Data Collection ICH GCP 4.9, 4.11, 5.5 B. IRB rules. STANDARD OPERATING PROCEDURES (SOP) TABLE OF CONTENTS. - Human Research Protections: Historical, Ethical & Regulatory Perspectives for Good Clinical Practices Susan C. Buskirk, RN, BSN, CCRC Executive Director Human ... - At least 5 voting members. - Randomization Practical Tips ... safety data in a timely fashion, ... endpoints which can be measured in a completely objective fashion are preferred ... A Blueprint For Clinical Research: Standard Operating Procedures. - A CRA or Clinical Research Associate monitors research studies and trials in a CRO (Contract Research Organization), a pharmaceutical company or a biotech company. During the Inspection ... 250 years The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research Kathryn C. Zoon, Ph.D Acting Director, RTRN Good Clinical Practice Series Coordinated by Mayer B. Davidson, M.D., Charles Drew University Federal Regulations & Good Clinical Practices (GCPs). Translational Research. ... Research Pathway in UKM Medical Centre and Clinical Trial Ward Infrastructure and SOPs Prof Dr Cheah Fook Choe Professor of Paediatrics (Neonatology). - ... strategy for web-based patients and study centre recruitment; ... QUALITY CONTROL. Improves the quality of the data collected, Utilized as a reference and guideline as to how, Excellent training source for new employees, All technologists doing the same task in the same, Description of the purpose of the procedure/task, Specific components to successfully perform the, Required personnel to perform all aspects of the, Appropriate patient population (as applicable), Required equipment, supplies, information and/or, Equipment settings, as appropriate and/or, Quality control procedures to assure optimal, Interpretation and reporting criteria, as, SOPs may be used as an educational tool to, familiarize the entire research team on the, train current and new employees to assure, receipt, administration, disposal and storage of. - FDA 'recommends' ICH GCPs is not law, but use is expected as a minimum standard ... Mt. Boasting an impressive range of designs, they will support your presentations with inspiring background photos or videos that support your themes, set the right mood, enhance your credibility and inspire your audiences. - Clinical senior Lecturer - School of Pharmacy Medicine, ... Why is she nauseous ? Standard Practices (1) •Monitoring:The act of overseeing the progress of a clinical trial, and of ensuringthat it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). - Pre-clinical proof of principle must be achieved ... Pre-clinical antitumor activity. Share yours for free! The Importance of Standard Operating Procedures (SOPs) in Clinical Trials. Can data go to PACs with a research code number? Winner of the Standing Ovation Award for “Best PowerPoint Templates” from Presentations Magazine. All clinical research investigators and staff are subject to review of their clinical research practices by local, regional, and/or federal regulatory authorities as well as sponsors, as appropriate. Approximately 60 concurrent ongoing clinical trials. Research Coordination Guidance The Committees on Human Research Serving University of Vermont & Fletcher Allen Health Care. Early Clinical Cancer Trials Phase I and II studies. The SOP should have a specific aim but be written in a general format to allow for easy implementation across a … PPT – The Importance of Standard Operating Procedures (SOPs) in Clinical Trials PowerPoint presentation | free to view - id: 464081-NGVmM, The Adobe Flash plugin is needed to view this content. Clinical Trials. Clinical trials are research studies involving people. Often the safety plan is combined with the DMP and is referred to as a Data and Safety - Genpro provides strategic consulting services in regulatory submissions, data submissions and early stage studies.Our expert pool of statisticians, regulatory experts and Submission specialists will help our clients at every stage of the trial. Designing data collection forms facilitates ... requirements Do you have an audit trail of ... European Clinical Research Infrastructure Network ... sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, GCP, insurance 5 - Adverse event reporting, ... A CRA or Clinical Research Associate monitors research studies and trials in a CRO (Contract Research Organization), a pharmaceutical company or a biotech company. My Background •Quorum Review IRB Created sets of SOPs for 4 processes Title: PowerPoint Presentation Author: Windows User Last modified by: Windows User Created Date: 9/23/2015 2:27:56 PM Document presentation format. STUDY FOLLOW-UP. ... Research Pathway in UKM Medical Centre and Clinical Trial Ward Infrastructure and SOPs, - Research Pathway in UKM Medical Centre and Clinical Trial Ward Infrastructure and SOPs Prof Dr Cheah Fook Choe Professor of Paediatrics (Neonatology). - Research Coordination Guidance The Committees on Human Research Serving University of Vermont & Fletcher Allen Health Care. Corrective and Preventive Actions. Their responsibility is to ensure adherence to clinical research guidelines, FDA approved methodology and SOPs (Standard Operating Procedures). Sinai School of Medicine & City University of New York 5/99 (FDA) ... | PowerPoint PPT presentation | free to download, Temple University Office of Clinical Trials Good Clinical Research Practices. All voting members must be full time or permanent part ... Voting members may fill more than one criterion for required membership ... - WRITING STANDARD OPERATING PROCEDURES (SOPs) Raymond C. Anderson, PhD When: Wednesday, August 23, 2006 9:00 11:00 am Where: Biomed I Room 205/207, Strategic consulting services in India - Genpro Research. The Strothers Association. - Food and Drug Administration. - ... preliminary evidence of efficacy and safety If the new treatment works well ... level decision rule ... the NULL Introduction to ROC curves ROC ... How to Become a Certified Clinical Research Associate. Applying expertise vs. autonomy of ... Stifle true dialogue (respect & review) ... ... strategy for web-based patients and study centre recruitment; ... QUALITY CONTROL. - Compliance Trainings will provide insight into various aspects of Food Compliance like prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and dietary supplements through industry experts. These SOP’s help the research teams, as recommendations for conducting research in the appropriate manner. Components of Quality Research. Through collaboration with the brightest minds in science and medicine MCW’s Centers are at the forefront of discovery and innovation. Since the role of a CRA is that of utmost responsibility, rigorous clinical research training and certification from recognized organizations is an essential requirement. They are applicable to the federal regulations common to clinical research of all types. The Strothers Association. What are the benefits of using SOPs? N2 SOPs - Developed through the collaboration of all N2 member organizations in an effort to standardize clinical research operations across Canada - Adopted by SJHH, HHS and McMaster in 2010 - SOPs are developed in compliance with HC regulations, ICH GCP, and TCPS2 - Updated every few years, the latest version being released May 15, 2015 Jackie Miefert, BS ... Politely try to minimize unrelated conversations. The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research. And they’re ready for you to use in your PowerPoint presentations the moment you need them. State of the School. Qualification Of A Central Lab for A Clinical Trial. We have developed several Standard Operating Procedures and Working Practice Documents to support the running of trials within the unit and to ensure compliance with the principles of Good Clinical Practice (GCP). View Sop In Clinical Research PPTs online, safely and virus-free! Medical/Statistical review of trial data. The, Data acquisition must be accurate and consistent, Data transfer must meet sponsors specifications, Patient information (demographics) must be, Gather your institutions SOPs that cover aspects, Gather your departmental SOPs that cover quality, Perform a gap analysis what GCP aspects are not, SOPs that indicate quality assurance is important, Attention to image standardization via SOPs, Sponsors expect you to be familiar with ICH GCP. Webinar On Investigator initiated trials- What are we doing to ensure human subject protection? Author: Dr Assem S. el Baghdady Last modified by: SERENAS Created Date: 11/18/2007 4:42:50 PM. Clinical Research Julie Doherty MSN, RN Director, Regulatory Compliance ... March 17, 2016. 21 CFR FDA (GCP, GMP or GTP Regs) ... to institutional policy. Or use it to find and download high-quality how-to PowerPoint ppt presentations with illustrated or animated slides that will teach you how to do something new, also for free. UofU Clinical Research SOP's March 17, 2020 University-wide Clinical Research Standard Operating Procedures (SOP) have been established. EXECUTIVE BOARD ... ECRIN-PPI European Clinical Research Infrastructures Network and biotherapy facilities Preparation Phase for the Infrastructure 2008-2011, - Title: PowerPoint Presentation Author: Jonas Ramsten Last modified by: PEGSOU Created Date: 9/17/2007 10:37:39 AM Document presentation format: Bildspel p sk rmen, The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research. - Treatment of Opioid Dependence. Who has access to the images or biologic data? - Introduction to Clinical Pharmacy a key role for pharmacists. Research should yield fruitful results for the good of society. DATA ANALYSIS. In simple terms an SOP is a written process and a way for the clinical site to perform a task the same way each time it is completed. Get ideas for your own presentations. - SOP s are found throughout ICH GCP Guidelines. Acting Commissioner: Andrew von Eschenbach, M.D. - Mining electronic health records: towards better research applications and clinical care Standardising the representation of clinical information: VA Research and Development 2002 Animal Research Update. An observation considered by Clinical Trials Quality Assurance Program (CTQA) to: Pose significant risk to the rights and/or safety of subjects Jeopardize data integrity Represent a major deviation from or deficiency in compliance with applicable regulations, guidelines, the protocol, standard operating procedures (SOPs) and/or policies Food and Drug Administration. Ex. Remarks of NIH Director Francis Collins FIC s Global Health Matters Newsletter NIH Town Meeting August 17, ... Indiana University Cyclotron Facility RESEARCH and Development at IUCF LIST OF SERVICES OVERVIEW Advanced Electron-Photon Facility (ALPHA) laser synchrotron X-ray ... SOP s are found throughout ICH GCP Guidelines. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. Food and Drug Administration. We have some of the best talent when it comes to adaptive and bayesian design. These records should include dates, quantities, 4.6.3, cont. Intraclass correlation coefficient. Closure/Archiving ... Training and Understanding in Clinical/Medical Terminology ... - Definition of a common set of criteria for risk evaluation, and of common monitoring strategies ... Uppdatering av det redan etablerade QA-systemet ... RTRN Good Clinical Practice Series Coordinated by Mayer B. Davidson, M.D., Charles Drew University Data Collection Standards for Clinical Trials. January 2006 ... Albertsons, Inc. $ 293,074. Centers. Clinical trials try to answer specific scientific questions to find better ways to prevent, detect, or treat diseases, or to improve care for people with diseases. Testing & Animal Disease Surveillance Sections; Michigan Dept Of Agriculture ... OBRR research is organized in parallel with product review down to the branch level. Street Address 207 Schwartz Center, 800 E. Summit St., Kent, OH 44242-0001 Mailing Address 800 E. Summit St. Kent, OH 44242 - European Clinical Research Infrastructure Network ... sponsoring 3 - Ethics 4 - Legislation, regulatory affairs, GCP, insurance 5 - Adverse event reporting, ... How to Become a Certified Clinical Research Associate. Preparing and Submitting Initial IRB Documents ... SOP provides general information that is to be utilized throughout any research study. Will she take it? Applying expertise vs. autonomy of ... Stifle true dialogue (respect & review) ... EUROPA ~ WP4 Clinical research Executive Organisation ( CREO) Paris, September 2004. should be included in the protocol but may be elucidated in a Standard Operating Procedure (SOP). University of Colorado School of Pharmacy. Many are downloadable. ... Methodologies for product review and surveillance. within-subject standard deviation ... Use Simple (Pearson) Correlation for Assessment of ... correlation coefficient ... - Title: Are We Ready for an Audit and Inspection as a Sponsor? All clinical trial information should be recorded, handled, and stored in a ... HCVRelated Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network. NIH guidelines. You may edit and adapt for your department. Define standard operating procedures (SOPs) as, List SOPs that exist in your institution and, Understand what additional SOPs will aid in, View SOPs from the perspective of the sponsor, a set of instructions with the force of a, an effective catalyst to drive performance, create the level of quality and accepted practice, the foundation of every good quality system, Clinical research SOPs are an important way to, Good Clinical Practices are guidelines for, Published by the International Conference on, International Conference on Harmonization, ICH consists of regulatory authorities from, ICH is considered the authority on clinical, develop scientific consensus through discussions, assure wide consultation of draft consensus, secure commitment by regulatory parties to, Safety management in clinical trials, including, Statistical principles for clinical trials, Choice of control groups in clinical trials, 8. Recordkeeping SOP no white out, no erasures, 42 CFR 482.53 Nuclear Medicine Services If, a) Standard organization and staffing. - MRC/DH Joint Project: Implementing UK Medicines for Human Use (Clinical Trials) Regulations ... signed consent form, medical record, investigation report or ONS ... Webinar On Patient Compliance in Drug Trials. The Clinical Investigator: Responsibilities in Medical Device Clinical Trials. Survival Techniques for FDA Audits Melissa P. DelBello, MD ViceChair of Clinical Research, Departmen. Title: PowerPoint Presentation Author: Jonas Ramsten Last modified by: PEGSOU Created Date: 9/17/2007 10:37:39 AM Document presentation format: Bildspel p sk rmen. Acting Commissioner: Andrew von Eschenbach, M.D. Radiopharmacy dosing records integrated into, 21CFR312.62 (b) Case histories. During the Inspection ... - 250 years The Regulation of Drug and Biological Products Introduction to the Principles and Practice of Clinical Research Kathryn C. Zoon, Ph.D Acting Director, - RTRN Good Clinical Practice Series Coordinated by Mayer B. Davidson, M.D., Charles Drew University Federal Regulations & Good Clinical Practices (GCPs), Training Clinical Data Managers A Joint Industry-Academic Perspective Society for Clinical Trials 2007 Annual Meeting Montreal, Canada. Policy MG.O-001 — Clinical Research Billing Compliance with Medicare Requirements (Version Date: 5/16/2016) Procedure MG.O-001.01 — OnCore Pathway to Billing Compliance (Version Date: 5/15/2018) Benefit of brochodilation? Microsoft Word sop Recruitment Of Participants integrity of the trial data and the compliance of the trial with GCP to be evaluated - Preparing and Submitting Initial IRB Documents ... SOP provides general information that is to be utilized throughout any research study. We will support you through the FDA interactions and data monitoring committee support. To describe the process for developing clinical research protocol of Investigator Driven studies at _____which includes human research participants. - a practical approach to the use of computerized systems in device clinical investigations fda requirements and expectations june 24, 2010 nih/fda workshop: Investigator-initiated%20Multi-center%20Trials. Medical/Statistical review of trial data. To view this presentation, you'll need to allow Flash. Called the 'FDA regs' ... Institutional Policies. Although most of these SOPs were developed for AIDS clinical trials, many of these documents can be modified and … - Preparing and Submitting Initial IRB Documents ... SOP provides general information that is to be utilized throughout any research study. Author: Dr Assem S. el Baghdady Last modified by: SERENAS Created Date: 11/18/2007 4:42:50 PM. Standard Operating Procedures (SOPs) in Clinical Trials are the standard documents that define the procedure, which must be followed to ensure that standards are followed while carrying out research. - CrystalGraphics offers more PowerPoint templates than anyone else in the world, with over 4 million to choose from. - The Importance of Standard Operating Procedures (SOPs) in Clinical Trials Final Draft CTN108: SOPs 11/30/09 * If the sponsor has not defined the imaging parameters ... | PowerPoint PPT presentation | free to view, A Blueprint For Clinical Research: Standard Operating Procedures. Atlanta, GA - April 25, 2006 ... Mid-Atlantic Node: Johns Hopkins Univ., Baltimore, MD; Medical College. Writing A Protocol. SOM Clinical Trials Office. Learn new and interesting things. Year 3 Peradeniya University SOP. - ICH GCP 2.13 - Systems with procedures that assure the quality of every aspect of the trial should be ... FOR MORE INFORMATION ON CLINICAL DATAMANAGEMENT COURSE VISIT :WWW.FINENESSINSTITUTE.COM. Routine checkups ... Training Clinical Data Managers A Joint Industry-Academic Perspective Society for Clinical Trials 2007 Annual Meeting Montreal, Canada. WRITING STANDARD OPERATING PROCEDURES (SOPs) Raymond C. Anderson, PhD When: Wednesday, August 23, 2006 9:00 11:00 am Where: Biomed I Room 205/207. Investigators should maintain, 4.6.4 The investigational product(s) should be, 4.6.5 The investigator should ensure that the, 4.6.6 The investigator, or a person designated by, Sec. -Activities ... A recommendation for 'Good Manufacturing Practice', first issued in by the World ... New Starter Models for Pharmaceutical Companies and Clinical Research Organisations (CROs) October 2011. ... EU Clinical Trials Directives Organisation and Implementation of Cancer Clinical Trials. January 2006 ... Albertsons, Inc. $ 293,074. Clinical Trials Office ... Belmont Report (1979) defined the differences between practice' ... Medical Center Community = Clinical Research. Do you have PowerPoint slides to share? SOPs are used to: Identify the responsible person for each task; Describe what is to be completed; Train staff; and; Monitor site performance. Lori Elder. - A CRA or Clinical Research Associate monitors research studies and trials in a CRO (Contract Research Organization), a pharmaceutical company or a biotech company. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. - Who should know the results and how shall we let them know? Mandy Vick Research Compliance Monitor Regulatory Support & Bioethics Core Institute of Translational Health Sciences vicka@uw.edu 1. Flagging if poss ... ECG/blood test results. STUDY FOLLOW-UP. JCRI's SOP's are located on located in our Confluence page: Microsoft Word sop Recruitment Of Participants. Their responsibility is to ensure adherence to clinical research guidelines, FDA approved methodology and SOPs (Standard Operating Procedures). If so, share your PPT presentation slides online with PowerShow.com. SOPs should contain enough detail to guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. FDA 'recommends' ICH GCPs is not law, but use is expected as a minimum standard ... Mt. - Responsibility for research success vs. responsibility for following guidance. Our procedures have been developed according to the specific work groups within ECTU. Many of them are also animated. Collect death certificates, discharge summaries and lab reports ... - 'In any medical study, every patient--including those of a control group, if any ... Elective medical/surgical procedures. DATA ANALYSIS. SOPs should include a procedure for documentation, and where the documents are kept and stored. Fundamentals of Clinical ... Trial Feasibility ... Temple University Office of Clinical Trials Good Clinical Research Practices. Safety training (ie, CPR, fire extinguisher, Sometimes these get complicated with nuclear. - This 1 hour virtual seminar will help you understand compliant issues researchers face while conducting clinical trials especially in the drug trials. 312.62 Investigator recordkeeping and record. - University of Colorado School of Pharmacy. Historical and contemporary foundations of research ethics and research regulation, - Title: PowerPoint Presentation Last modified by: Prof Clement Adebamowo Created Date: 1/1/1601 12:00:00 AM Document presentation format: On-screen Show, The Importance of Standard Operating Procedures (SOPs) in Clinical Trials. ... Human Subjects Protection in Health Services Research: A Researcher Perspective. Their responsibility is to ensure adherence to clinical research guidelines, FDA approved methodology and SOPs (Standard Operating Procedures). 2006. Research should yield fruitful results for the good of society. The Medicines for Human Use (Clinical Trails) Regulations state that clinical trials will be conducted according to the principles of Good Clinical Practice.. Regulation 31A requires that a readily available Trial Master File is kept, which contains the essential documents relating to that clinical trial. The documents below contain standards operating procedures (SOPs) for clinical research investigators and research … 2006. DGHI is pleased to share these documents with others who are working in resource-limited locations. • FDA related studies - 2 years after the data has been submitted to FDA or the study is closed. The main purpose of clinical trials is to “study” new medical products in people. SOP Writing for Clinical Research Write down what you do, do what is written down! Since the role of a CRA is that of utmost responsibility, rigorous clinical research training and certification from recognized organizations is an essential requirement. Sec. Jackie Miefert, BS ... Politely try to minimize unrelated conversations. STUDY REPORT. Clinical trials are invaluable in testing new treatments, drugs and technologies. standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidances. - ICH GCP 2.13 - Systems with procedures that assure the quality of every aspect of the trial should be ... HCV-Related Services in Substance Abuse Treatment Settings: The NIDA Clinical Trials Network. Components of Quality Research. Food and Drug Administration. Clinical Research sop Template Free . Thank you for our ... Internal Auditing in Research: The QA Process Research Education Series February 14, 2011, - Internal Auditing in Research: The QA Process Research Education Series February 14, 2011 Sarah Dutkevitch, RN, OCN, Clinical Research Nurse Specialist, Career Opportunities in Biostatistics at the Duke Clinical Research Institute. State of the School. The Campbell Foundation's SOPs help define the clinical research group’s standard practices and daily processes conducted to assure … Standard Operating Procedures (SOPs) are uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization. SSA integrated within standard NHS research governance review ... MRCDH Joint Project: Implementing UK Medicines for Human Use Clinical Trials Regulations Trial Manag. - Beautifully designed chart and diagram s for PowerPoint with visually stunning graphics and animation effects. Developing Core Competency in Clinical Research, Human Research Protections: Historical, Ethical. • HHS 45 CFR 46 – 3 years after research has been completed • ICH-GCP – 2 years after last approval of an marketing Regulatory (NRC or state) guidelines direct the, 4.6.3 The investigator/institution and/or a. - Good Clinical Practices and the Clinical Research Process ... 2. PowerShow.com is a leading presentation/slideshow sharing website. Eboni Cochran West End ... SoCRA The Society of Clinical Research Associates. Kaiser Permanente 110,000. Minimum Standards and Exemplary Attributes of Clinical Trial Sites, - Minimum Standards and Exemplary Attributes of Clinical Trial Sites S. Gail Eckhardt, MD (Slides prepared by Robin Zon, MD), Why%20you%20Should%20Care%20about%20Activities%20Related%20to%20Clinical%20Trials%20. It's FREE! SOPs Suggested for Sites Conducting Research . Clinical Research Center Standard Operating Procedures. Research Records/Retention • Six years if HIPAA Authorizations are obtained (HIPAA requirement). Introduction to Clinical Pharmacy a key role for pharmacists. - Called the 'FDA regs' ... Institutional Policies. - Intraclass correlation coefficient. And, best of all, most of its cool features are free and easy to use. NIH guidelines. Clinical Research Policies and SOPs Joint GU/MHRI Policies and Procedures. If so, share your PPT presentation slides online with PowerShow.com. User Last modified by: Prof Clement Adebamowo Created Date: 9/23/2015 2:27:56 Document... //Louisville.Edu/Research/Clinicaltrials/About/University-Clinical-Res earch... Luther L. Brown, Jr else in the protocol but may be elucidated a! 11/18/2007 4:42:50 PM SOPs depending on the protocol but may be submitted several times - FDA 'recommends ' ICH is! Initial IRB Documents... SOP provides general information that is to be utilized throughout any Research study our Confluence:... 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Researcher Perspective CrystalGraphics 3D Character slides for PowerPoint - Pre-clinical proof of principle must be achieved... antitumor... Color, shadow and lighting effects SSA integrated within Standard NHS Research governance...! Preparing and Submitting Initial IRB Documents... SOP provides general information that is to ensure adherence to Clinical Infrastructure... Md ViceChair of Clinical Research Practices seminar will help you understand compliant issues researchers face while conducting Clinical Trials Annual! Aligning our Clinical Research Standard Operating Procedure ( SOP ) Michigan Dept of.... Else in the protocol but may be submitted several times cool features Free...