MindMap Gallery clinical trial preparation stage
This is a mind map about the preparation stage of clinical trials, which introduces the main contents of the preparation and completion stages of clinical trials.
Edited at 2024-04-10 17:20:00Avatar 3 centers on the Sully family, showcasing the internal rift caused by the sacrifice of their eldest son, and their alliance with other tribes on Pandora against the external conflict of the Ashbringers, who adhere to the philosophy of fire and are allied with humans. It explores the grand themes of family, faith, and survival.
This article discusses the Easter eggs and homages in Zootopia 2 that you may have discovered. The main content includes: character and archetype Easter eggs, cinematic universe crossover Easter eggs, animal ecology and behavior references, symbol and metaphor Easter eggs, social satire and brand allusions, and emotional storylines and sequel foreshadowing.
[Zootopia Character Relationship Chart] The idealistic rabbit police officer Judy and the cynical fox conman Nick form a charmingly contrasting duo, rising from street hustlers to become Zootopia police officers!
Avatar 3 centers on the Sully family, showcasing the internal rift caused by the sacrifice of their eldest son, and their alliance with other tribes on Pandora against the external conflict of the Ashbringers, who adhere to the philosophy of fire and are allied with humans. It explores the grand themes of family, faith, and survival.
This article discusses the Easter eggs and homages in Zootopia 2 that you may have discovered. The main content includes: character and archetype Easter eggs, cinematic universe crossover Easter eggs, animal ecology and behavior references, symbol and metaphor Easter eggs, social satire and brand allusions, and emotional storylines and sequel foreshadowing.
[Zootopia Character Relationship Chart] The idealistic rabbit police officer Judy and the cynical fox conman Nick form a charmingly contrasting duo, rising from street hustlers to become Zootopia police officers!
clinical trial preparation stage
Center research
Before research
According to the research plan, checklist and requirements
Appointment time and location person
Specify the survey format: telephone. Email, real-time surveys, etc.
Preparation
Document preparation: confidentiality agreement, introduction to survey questionnaire plan
Prepare yourself: Familiarize yourself with the research process and plan in advance
During research
Enrollment capacity survey, personnel and qualification survey, information and document storage, facilities and equipment, drug management process, local laboratory process, institutional and ethical process and financial process
After research
Organize research information
Timely follow up on problems discovered during the research process and improve the research report
Archive research documents
Institutional project establishment
Before project establishment
Obtain the new project application process - agency work guide, available on the agency website
When the project is established
Clarify the requirements for documents to be submitted for review: number of copies, binding requirements, seal requirements, signature requirements, and submit documents in accordance with project establishment requirements.
After project establishment
Get project approval receipt
ethical review
Preparation before meeting
Understand the center's ethics review process, prepare documents, and assist the PI in preparing materials.
Follow up after the meeting
Track the first ethics review opinions and obtain ethics approval documents
Amendment review
Updates to research protocols and informed consent forms, etc.
Suspend/terminate review
Registration and human remains
CDE filing, provincial bureau filing, genetic office
contract signing
Clinical Research Master Agreement
Clearly sign the process
Contract signing requirements
Fees and bills
CRC Service Agreement
Clearly sign the process
Contract signing requirements
Fees and bills
Milestone 3 in the experiment: data cleaning and control
Milestone 2 in the experiment: expected time point for completion of the experiment
Milestone 1 in the experiment: The first subject is enrolled
Clinical trial completion stage
Data cleaning
Data integrity check, including record integrity, field integrity, and verification of data consistency
center closed
All subjects have completed follow-up, compensation has been paid, and the data has been locked.
Before closing: Understand the ethics committee center closing process, data preparation, financial settlement, test sample recovery, etc.
Improve reporting on closed centers
Official filing
Submit a filing application and submit the filing application for the experimental completion stage to the relevant department, attaching the required materials
Audit and evaluation: Relevant departments complete the audit and evaluation to ensure the compliance and integrity of the test
Filing approval: After passing the review, the relevant departments will give filing approval and provide corresponding certificates or documents.
Filing information formula
clinical trial stage
Start-up preparation and kick-off meeting
Start preparation
Prepare required information
Before the kick-off meeting
Notify personnel, arrange location, time, meeting schedule, etc.
Kick-off meeting
Debugging, preparing documents, implementing signatures, etc.
After the kick-off meeting
Organizing venue documents
Subject recruitment
Find participants who meet research requirements through various channels
informed consent
Informed Consent Notice
Informed consent signing
Documentation of the informed consent process
Informed consent management
Subject screening and enrollment/visit
Before screening visit
Contact Subject
Receive subjects during enrollment/follow-up and guide them to complete examinations
After screening and follow-up: tracking inspection results, organizing and archiving original data
Handling of special situations (loss to follow-up): Understand the reasons for loss to follow-up and assist in keeping records