临床试验没有事儿——GCP纵横杂谈

Brand: 科学技术文献出版社    Sold By: EM China
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈
临床试验没有事儿——GCP纵横杂谈

临床试验没有事儿——GCP纵横杂谈

Brand: 科学技术文献出版社    Sold By: EM China
$42.79 In Stock
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临床试验没有事儿——GCP纵横杂谈

临床试验没有事儿——GCP纵横杂谈

$42.79

内容简介

本书内容主要来自临床试验领域资深从业人员在多年耕耘与实践

中的工作体会、心得总结和思考,积累成文,汇集成册,期望与更

多同行分享交流,也期望对业内同行有一定参考价值。全书涉及临

床试验多个方面和不同视角与维度,有涉及法规的,也有操作层面

的;有自己的实践体会,也有海外见闻。为方便阅读,全书共分为6

篇,分别为机构管理篇、试验技术操作篇、试验质量篇、伦理审查

Product Details

内容简介

本书内容主要来自临床试验领域资深从业人员在多年耕耘与实践

中的工作体会、心得总结和思考,积累成文,汇集成册,期望与更

多同行分享交流,也期望对业内同行有一定参考价值。全书涉及临

床试验多个方面和不同视角与维度,有涉及法规的,也有操作层面

的;有自己的实践体会,也有海外见闻。为方便阅读,全书共分为6

篇,分别为机构管理篇、试验技术操作篇、试验质量篇、伦理审查

与受试者保护篇、综合篇和海外攻玉篇。

 

目  录
目 录

篇 机构管理篇1

我国药物临床试验机构发展的现状与问题探讨 2
试验合同签署关键点之一:合同主体问题 6
试验合同签署关键点之二:国外申办者授权委托书的法律效力 8
制定临床试验合同中的主要条款分析11
专业组GCP 秘书,还要继续游离于试验项目之外吗?17
探讨医院引入临床研究协调员及第三方稽查员19
再议CRO 中心实验室的合规性24
临床试验信息化建设,各个系统应贯通26
药物临床试验医院信息系统免费医嘱系统的应用29
转变试验机构管理模式,为临床试验保驾护航33
书摘插画
插图

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

内容简介

本书内容主要来自临床试验领域资深从业人员在多年耕耘与实践

中的工作体会、心得总结和思考,积累成文,汇集成册,期望与更

多同行分享交流,也期望对业内同行有一定参考价值。全书涉及临

床试验多个方面和不同视角与维度,有涉及法规的,也有操作层面

的;有自己的实践体会,也有海外见闻。为方便阅读,全书共分为6

篇,分别为机构管理篇、试验技术操作篇、试验质量篇、伦理审查

与受试者保护篇、综合篇和海外攻玉篇。

 

目  录
目 录

篇 机构管理篇1

我国药物临床试验机构发展的现状与问题探讨 2
试验合同签署关键点之一:合同主体问题 6
试验合同签署关键点之二:国外申办者授权委托书的法律效力 8
制定临床试验合同中的主要条款分析11
专业组GCP 秘书,还要继续游离于试验项目之外吗?17
探讨医院引入临床研究协调员及第三方稽查员19
再议CRO 中心实验室的合规性24
临床试验信息化建设,各个系统应贯通26
药物临床试验医院信息系统免费医嘱系统的应用29
转变试验机构管理模式,为临床试验保驾护航33
书摘插画
插图

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

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