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id="left-area"> <div class="woocommerce-notices-wrapper"></div><div id="product-30894" class="et_pb_post product type-product post-30894 status-publish first instock product_cat-cpe product_cat-drug-development-cpe has-post-thumbnail virtual taxable purchasable product-type-simple"> <div class="clearfix"> <div class="summary entry-summary"> </div> </div><div class="et-l et-l--post"> <div class="et_builder_inner_content et_pb_gutters3 product"> <div class="et_pb_section et_pb_section_0 et_pb_with_background et_pb_section_parallax et_section_regular" > <div class="et_pb_row et_pb_row_0 et_pb_equal_columns"> <div class="et_pb_column et_pb_column_1_2 et_pb_column_0 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_text et_pb_text_0 et_pb_text_align_left et_pb_bg_layout_dark"> <div class="et_pb_text_inner"><h1>Clinical Development 101: 聽General Principles</h1> <h2><span>CPE Credit: 1.0</span></h2></div> </div><div class="et_pb_module et_pb_text et_pb_text_1 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This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.</span></p></div> </div> </div><div class="et_pb_column et_pb_column_1_2 et_pb_column_1 ag-vertical-align et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_image et_pb_image_0"> <span class="et_pb_image_wrap "><img fetchpriority="high" decoding="async" width="1080" height="1080" src="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/07/23095533/CPE-Price-Box-Clinical-Development-101_-General-Principles.jpg" alt="" title="CPE Price Box Clinical Development 101_ General Principles" srcset="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/07/23095533/CPE-Price-Box-Clinical-Development-101_-General-Principles.jpg 1080w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/07/23095533/CPE-Price-Box-Clinical-Development-101_-General-Principles-980x980.jpg 980w, 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et_pb_wc_add_to_cart_0 et_pb_hide_input_quantity et_pb_hide_stock et_pb_fields_label_position_default et_pb_bg_layout_ et_pb_text_align_center"> <div class="et_pb_module_inner"> <form class="cart" action="https://biotechprimer.com/product/clinical-development-101-general-principles-cpe/" method="post" enctype='multipart/form-data'> <div class="quantity"> <label class="screen-reader-text" for="quantity_6746fb1d41de3">Clinical Development 101: General Principles | CPE quantity</label> <input type="number" id="quantity_6746fb1d41de3" class="input-text qty text" name="quantity" value="1" aria-label="Product quantity" min="1" max="" step="1" placeholder="" inputmode="numeric" autocomplete="off" /> </div> <button type="submit" name="add-to-cart" value="30894" class="single_add_to_cart_button button alt">Add to cart</button> </form> </div> </div> </div> </div> </div><div class="et_pb_section et_pb_section_1 et_section_regular" > <div class="et_pb_row et_pb_row_2"> <div class="et_pb_column et_pb_column_2_3 et_pb_column_6 et_pb_css_mix_blend_mode_passthrough"> <div class="et_pb_module et_pb_blurb et_pb_blurb_0 et_animated et_pb_text_align_left et_pb_blurb_position_left et_pb_bg_layout_light et_pb_blurb_position_left_tablet et_pb_blurb_position_top_phone"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><a href="#"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" width="205" height="204" src="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-1-17.png" alt="" srcset="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-1-17.png 205w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-1-17-150x150.png 150w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-1-17-100x100.png 100w" sizes="(max-width: 205px) 100vw, 205px" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-17747" /></span></a></div> <div class="et_pb_blurb_container"> <h2 class="et_pb_module_header"><a href="#">Section 1: Clinical Development Introduction</a></h2> <div class="et_pb_blurb_description"><p><span style="font-weight: 400">Describes the key milestones for drug development, specifically focusing on clinical development. Important terms including evidence-based medicine, translational medicine, and patient-centric clinical trials are explained. Finally, the purposes for which clinical trials are conducted are explored.</span></p></div> </div> </div> </div><div class="et_pb_module et_pb_blurb et_pb_blurb_1 et_animated et_pb_text_align_left et_pb_blurb_position_left et_pb_bg_layout_light et_pb_blurb_position_left_tablet et_pb_blurb_position_top_phone"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><a href="#"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" width="205" height="204" src="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165810/Section-2-24.png" alt="" srcset="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165810/Section-2-24.png 205w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165810/Section-2-24-100x100.png 100w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165810/Section-2-24-150x150.png 150w" sizes="(max-width: 205px) 100vw, 205px" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-17793" /></span></a></div> <div class="et_pb_blurb_container"> <h2 class="et_pb_module_header"><a href="#">Section 2: Clinical Trials - Basic Principles</a></h2> <div class="et_pb_blurb_description"><p><span style="font-weight: 400">Explains how risk management is approached in terms of scientific method, Good Clinical Practices (GCPs), and trial design. Bias, blinding, randomization and endpoints are all explained in detail.</span></p></div> </div> </div> </div><div class="et_pb_module et_pb_blurb et_pb_blurb_2 et_animated et_pb_text_align_left et_pb_blurb_position_left et_pb_bg_layout_light et_pb_blurb_position_left_tablet et_pb_blurb_position_top_phone"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><a href="#"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" width="205" height="204" src="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-3-17.png" alt="" srcset="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-3-17.png 205w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-3-17-150x150.png 150w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20165814/Section-3-17-100x100.png 100w" sizes="(max-width: 205px) 100vw, 205px" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-17745" /></span></a></div> <div class="et_pb_blurb_container"> <h2 class="et_pb_module_header"><a href="#">Section 3: Conducting Clinical Trials</a></h2> <div class="et_pb_blurb_description"><p><span style="font-weight: 400">Explains the various clinical trial participants and their roles, identifies the basic elements of a clinical protocol, describes informed consent, discusses inclusion/exclusion criteria, lists the steps in data management and reporting, and reviews the concept of clinical trial transparency.</span></p></div> </div> </div> </div><div class="et_pb_module et_pb_blurb et_pb_blurb_3 et_animated et_pb_text_align_left et_pb_blurb_position_left et_pb_bg_layout_light et_pb_blurb_position_left_tablet et_pb_blurb_position_top_phone"> <div class="et_pb_blurb_content"> <div class="et_pb_main_blurb_image"><a href="#"><span class="et_pb_image_wrap et_pb_only_image_mode_wrap"><img decoding="async" width="635" height="540" src="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20170146/LI-In-Bug.png" alt="" srcset="https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20170146/LI-In-Bug.png 635w, https://btpimg.s3.us-east-2.amazonaws.com/wp-content/uploads/2024/01/20170146/LI-In-Bug-480x408.png 480w" sizes="(min-width: 0px) and (max-width: 480px) 480px, (min-width: 481px) 635px, 100vw" class="et-waypoint et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-15951" /></span></a></div> <div class="et_pb_blurb_container"> <h2 class="et_pb_module_header"><a href="#">Attach Your Course Certificate to Your LinkedIn Certification and License Profile</a></h2> <div class="et_pb_blurb_description"><h5>Learn How</h5> </div> </div> </div> </div> </div><div class="et_pb_column et_pb_column_1_3 et_pb_column_7 et_pb_css_mix_blend_mode_passthrough et-last-child"> <div class="et_pb_module et_pb_blurb et_pb_blurb_4 et_animated 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et_pb_animation_top et_pb_animation_top_tablet et_pb_animation_top_phone wp-image-17279" /></span></a></div> <div class="et_pb_blurb_container"> <h2 class="et_pb_module_header"><a href="#">Five Takeaways</a></h2> <div class="et_pb_blurb_description"><p> </p> <ol> <li style="text-align: left;">Enumerate the clinical trial phases in order, explain the purpose of each, and list their milestones.</li> <li style="text-align: left;">Identify the key individuals and groups involved in clinical trials and explain their roles in detail.</li> <li style="text-align: left;">Define foundational drug development concepts to control bias, such as control groups, blinding, and randomization.</li> <li style="text-align: left;">Choose the appropriate study design criteria to reduce bias and ensure patient safety.</li> <li style="text-align: left;">Compile a list of regulatory studies and the data each collects to enable follow-on studies.</li> </ol></div> </div> </div> </div><div 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