ES’ SOCRA CCRP Exam Study Guide: An Ultimate Resource for the SOCRA CCRP Exam Preparation
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The document is an advertisement for the ES' SOCRA CCRP Exam Study Guide, a comprehensive study guide created by Ernie Sakchalathorn to help individuals prepare for the SOCRA Certified Clinical Research Professional (CCRP) certification exam. The study guide contains over 100 pages summarizing exam materials, a navigation menu, an outline of the certification process, and tips from the author's experience passing the exam with a 96% score. The study guide aims to help users efficiently study on their own time at home, unlike expensive in-person review courses that require travel and only provide brief overviews.
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Data Model Design:
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Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
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Certified Internet Research Specialist (CIRS™) Training Program Syllabus for ...
Certified Internet Research Specialist (CIRS™) Training Program Syllabus for ...Olivia Russell CIRS, MS
The CIRS™ is the first of its kind - A Gold Standard Certification for Practitioners of Online Research. This course is developed as a Self-study Training Guide to assist you in preparing for the CIRS examination. The training guide book is most suitable as a Practical Guide or Reference for mastering the art of Online Research by anyone that uses the Internet as a primary tool for information gathering - In this course, you will learn about the practical approach in building complex search queries and the search tools. If you become a CIRS™ you are expected to be knowledgeable in selecting the best search tools and be proficient in building Internet search queries. You would develop sufficient knowledge of the Internet Laws and related ethical issues. This program is available in both Self-study and Online Training Classes. No prior knowledge or experience in research is required to take this course.
https://aofirs.org/certifications/cirs-exam-syllabusInternship PowerPoint
Taylor Lott completed a 180-hour health science internship at Clemson University International Center for Automotive Research (CU ICAR). Her responsibilities included collecting data from driving simulator participants, inputting the data into Excel, and writing a literature review on defensive driving courses. She gained experience in research techniques, data collection, and working with a diverse team. The internship helped her apply classroom knowledge and confirmed her interest in pursuing a research career.
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Define Study Requirements:
Understand the specific requirements of the study and the data to be collected. This includes variables, data types, formats, and any specific rules or calculations required for data validation and derivation. Consult with the study team and stakeholders to determine the necessary data elements.
Data Model Design:
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Data Dictionary:
Create a comprehensive data dictionary that provides a detailed description of each data element, including its name, definition, data type, length, format, allowable values, and any validation or derivation rules. The data dictionary serves as a reference for data entry and validation checks.
Database Schema:
Design the database schema based on the data model and data dictionary. Identify the tables, fields, and relationships needed to store the data. Determine primary and foreign keys to establish relationships between tables. Normalize the schema to reduce redundancy and improve data integrity.
Data Capture Forms:
Design user-friendly data capture forms to facilitate efficient and accurate data entry. Align the form layout with the data model and data dictionary. Include necessary data validation checks and provide clear instructions or prompts for data entry.
Data Validation and Quality Checks:
Incorporate data validation checks to ensure data accuracy and completeness. Implement range checks, format checks, consistency checks, and logic checks to identify and prevent data entry errors. Include data quality control processes to identify and resolve data discrepancies or anomalies.
Security and Access Controls:
Implement appropriate security measures to protect the confidentiality, integrity, and availability of the data. Define user roles and access levels to control data access and modification. Employ encryption, authentication, and audit trails to ensure data security and compliance with regulatory requirements.
Data Extraction and Reporting:
Consider the need for data extraction and reporting capabilities. Design mechanisms to extract data from the database for analysis or reporting purposes. Implement data export functionalities in commonly used formats, such as CSV or Excel, or integrate with reporting tools or systems.
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Monitoring and auditing are important quality control activities in clinical trials. Monitoring ensures accurate and compliant conduct of trials, while auditing independently evaluates trial conduct and compliance. Key aspects include:
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ES’ SOCRA CCRP Exam Study Guide: An Ultimate Resource for the SOCRA CCRP Exam Preparation
- 1. SOCRA CCRP Exam - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification. By http://www.clinicalresearchas sociatecra.com/studyguide/
- 2. ES’ SOCRA CCRP Exam Study Guide: An Ultimate Resource for the SOCRA CCRP Exam Preparation Professional certification can provide added credentials for those who look for greater career success. The Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates (SOCRA) is a professional certification for those in the clinical research industry. The ES’ SOCRA CCRP Exam Study Guide is a comprehensive study guide that may help with preparation for those who plan to take the SOCRA CCRP exam. Why Do I Need A Study Guide When I Already Got the Reference Manual From SOCRA?
- 3. If you have already registered for the SOCRA CCRP exam, you should receive the SOCRA Certification Program Reference Manual in the mail. This manual is a good reference material. But imagine reading through the 21 CFR Parts 11, 50, 56, 312, 812, 45 CFR Part 46, and ICH GCP (E6) from start to finish, it can be quite grueling. By the end of it, how much information will you really get out of it? Also, the SOCRA Certification Program Reference Manual does not contain any industry experience from an industry insider whatsoever. It’s just a printout of regulations, that’s all it is. What About SOCRA Clinical Research Professional Certification Preparation and GCP Review Course? SOCRA offers a 1 day in-person Clinical Research Professional Certification Preparation and GCP Review Course at various locations and dates in the U.S. and Canada. I had attended this course prior to my SOCRA CCRP exam in September 2013. Although the information presented on this course can be beneficial, and I would recommend this to anyone taking the exam, there are limitations to this course:
- 4. •The cost for this preparation course is quiet considerable ($295 for SOCRA member, $370 for non-member). This is in addition to the cost of SOCRA membership ($75/yr) and the CCRP exam fee ($195). •The course is offered only a hand full of times per year in different locations. If you do not live near the location where the course will be held, traveling is involved. This means more costs for flight, hotel, car rental, and daily expenses. •The information is condensed into compact format in order to fit the 1 day time limit. •The information presented can be found from publicly available sources and is not a substitute to one’s own studying.
- 5. In my opinion, my own time in studying and taking notes from publicly available relevant information (various GCP trainings, CFR, ICH’s GCP, industry websites, etc.) and years of industry experience helped me much more. Another reason is that it was impossible for me to retain information from a 1 day compact course. It was useful for me to summarize key information from my own studying and absorb them at my own pace. If I were to attend this 1 day course without spending the time to study on my own prior to the exam, I would not have aced this exam or even passing it. How ES’ SOCRA CCRP Study Guide Can Help Save You Time and Sanity Instead of trying to plow through countless FDA regulations, guidelines, and industry practices, imagine if there is a Study Guide that helps summarize all those materials in an easy to digest format in bullet points. Imagine if you can click and search different topics in seconds. Imagine if you can browse through and learn the information at your own place in the comfort of your home. Imagine if there are tips and suggestions from someone in the industry who had gone through the exam and aced it with flying colors.
- 6. Imagine no more Imagine no more. I have compiled the note I took when I was studying for the SOCRA CCRP exam in September 2013. I have named it “ES’ SOCRA CCRP Study Guide” (ES stands for Ernie Sakchalathorn). From these notes, I was able to pass the SOCRA CCRP exam with a score of 96% (I answered 130 questions correctly out of 135 questions total, click HERE to see my score letter). Inside this Study Guide, there are: •100+ Pages of Complete and Outlined Summaries of Materials for the SOCRA CCRP Exam •Sidebar Navigation Menu with Clickable & Expandable Links to Any Section •A Complete Bullet Outline of The Entire SOCRA CCRP Certification Process •Personal Tips From My Industry Experience Both As a CRC And a CRA •Updated to apply to new exam outline for exams to be held after June 1, 2014
- 7. Author’s Profile: My name is Polachai Ernie Sakchalathorn and I'm the guy behind http://www.clinicalresearchassociatecra.com/ I have been in clinical research since 2007. I am currently an In-House Senior Clinical Research Associate working for a drug company in San Francisco. You can learn more about the ES’ SOCRA CCRP Study Guide at http://www.clinicalresearchassociatecra.com/studyguide/ .