the ich gcp guidelines citi

The IB also gives insight to help the clinical direction of their research subjects throughout the course of this clinical trial. The main things that monitors do are: (a) Make sure that subjects' rights and wellbeing are protected. Additional available modules cover a range of topics from humanitarian use devices, cultural competence, advanced issues in consent, working with different populations, community-based research, phase 1 research, clinical trial agreements, public health research, and single IRB review. It does not store any personal data. The IRB/IEC should do its job according to written operating procedures. Critical documents are those that allow us to understand a study and the quality of data generated from it. Investigators are ultimately responsible for the conduct of a clinical trial per U.S. Food and Drug Administration (FDA) regulations at 21 CFR 56 and per ICH E6(R2) Good Clinical Practice (GCP) guideline. No subjects should be admitted to a trial until the IRB/IEC has approved it in writing. The investigator is the leader of the group and might be known as the researcher. INVESTIGATOR 5. This cookie is set by Hotjar. You'll have access to jobs at some of the top companies operating in this field, and you'll be able to contribute your knowledge and expertise to their scientific studies. You'll also be able to demonstrate that you're adhering to the highest ethical and scientific standards possible. The report must also include a summary of the track reviewed along with the track's statements regarding any substantial findings/facts, deviations and deficiencies, decisions and actions taken or to be taken, and/or activities recommended to procure compliance. The trial should have a purpose that will help the person being tested. Vulnerable Subjects are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. The host needs to: (a) make sure that the investigational product(s) are delivered on time to this investigator(s). The sponsor should set up the trial and assign most responsibilities before it starts. It provides a random-number client security token. If the product is promoted and its pharmacology is widely known by medical professionals, a comprehensive IB might not be necessary. Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. 2. the Principles of Ich Gcp E6 (R2) Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. This cookie is set by Polylang plugin for WordPress powered websites. The purpose of this cookie is to synchronize the ID across many different Microsoft domains to enable user tracking. E6 has been amended to promote the implementation of advanced and more effective methods to clinical trial design, conduct, supervision, documenting, and reporting. The name and signature of the investigator(s)) who is/are responsible for conducting the trial, along with the address and phone number(s) of the trial site(s). 5.1 Quality Assurance and Quality Control. One of the key improvements is the new definition of a licensed copy of a situation report form (1.11). The COI Basic course is designed to satisfy training requirements associated with these regulations. 4. This cookie is used for registering a unique ID that identifies the type of browser. This cookie is set when the customer first lands on a page with the Hotjar script. Yes, a course containing all of the modules and completed after the courses effective date for GCP mutual recognition will contain a statement in the Completion Reports Course Transcript description field that identifies: This statement will also confirm that the learner has completed all the attested CITI Program modules from the course to meet the minimum criteria for ICH GCP training identified by TransCelerate BioPharma. These records must include dates, numbers, batch/serial numbers, expiration dates (if applicable), and the code numbers assigned to the investigational product(s) and trial subjects. This cookies are used to collect analytical information about how visitors use the website. ICH Guidance Documents | FDA This information is used to compile report and improve site. OMB Control Number: 0910-0843Expiration Date: 09/30/2023. ICH E6 describes standards that apply to: Investigators, sponsors, and IRBs In the United States, following the ICH E6 guideline is: The investigator should provide evidence of their qualifications with a resume or other documentation if requested. This cookie is used by Google Analytics to understand user interaction with the website. Any changes must also have the amendment number(s) and date(s). ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. They will also check to see if the investigator is only enrolling qualified subjects. The Coordinating Investigator is responsible for coordinating the investigators at several centers participating in a multicentre trial. The Independent Ethics Committee (IEC) is a body made up of caregivers and non-medical associates. A serious adverse event (SAE) or serious adverse drug reaction (Serious ADR) is any negative medical occurrence that, at any dose: - results in death, - is life-threatening, - requires a hospital stay or makes a current hospital stay longer, - causes significant disability or incapacity, or - is a congenital anomaly/birth defect. We also use third-party cookies that help us analyze and understand how you use this website. CITI Program GCP Training ICH E6(R2) | CITI Program The sponsor may also want to include a statement asking the investigator/recipients to keep the information in the IB private. Status: Step 5. These changes have been made in section 5.18.3 (Extent and Nature of Monitoring) and include the following improvements: "The host must create a systematic, guaranteed, risk-based method of tracking clinical trials. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. ICH-GCP Guidelines - SlideShare In emergency situations, when it is not possible to get permission from the person beforehand, we should try to get permission from their legally acceptable representative. The statement should include the name of the product being studied, all of the active ingredients, what the product is expected to do, and why the study is being done. Data handling and record keeping must be done according to the protocol. Introduction Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Please review our. (c) At least one member who is independent of the institution/trial site. CITI GCP Training Flashcards | Quizlet This cookie is set by GDPR Cookie Consent plugin. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. The sponsor must tell the investigator(s)/association(s) in writing when they need to keep documents and when they can get rid of them. 5.13 Manufacturing, Packaging, Labeling, and Coding Investigational Product(s). The statement should also explain how the product will be tested.7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation. This cookie is a browser ID cookie set by Linked share Buttons and ad tags. GLOSSARY 2. The IRB/IEC should have a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is used by Recording filters to identify new user sessions. It stores a true/false value, indicating whether this was the first time Hotjar saw this user. This is set by Hotjar to identify a new users first session. The timing and methods for assessing, recording, and assessing safety parameters must also be described. It helps in identifying the visitor device on their revisit. The ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. The IRB/IEC may request more information to be given to subjects than is outlined in paragraph 4.8.10 when the additional information would help protect the subjects' rights, safety and/or well-being. Any trial-related responsibilities and functions not specifically transferred to and assumed by a CRO are retained by the host. The person conducting the study must also sign the form. Enroll now in our Good Clinical Practice courses. This module covers the revisions to the International Council for Harmonistion (ICH) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2), including a breakdown of the changes by section with summaries and analysis. It might make more sense to create a new definition for computer validation (1.61) and renumber the definitions for vulnerable themes and well-being into 1.62 and 1.63, respectively. the ich gcp guidelines citi Clinical Research Blog | Certified This includes the study number, compound or accepted generic title, and transaction name(s). The cookie is set by Wix website building platform on Wix website. 7.2 General Considerations the IB should comprise: The title page should include the name of the person hosting the study, as well as the identification of every investigational product. 1 . Subinvestigators are any members of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions. The cookie is set by Wix website building platform on Wix website. The certificate you will earn upon completing our GCP training program is an acknowledgment of your eligibility to work as a clinical research professional anywhere in the world. The previous modification increases section 8.1 (Introduction) the following improvements:"[the] host and investigator/institution need to keep a listing of the place(s) of the individual key documents. The storage method (no matter the media used) need to supply for record identification, research, and recovery. The GCP renovation to the international guidelines will surely reflect this new era in clinical trials. Organizational administrators can add the Overview of ICH GCP E6(R2) Revisions (ID:19277) module to their learners gradebooks. The person in charge of the investigation or the pharmacist should keep records of when the product is delivered to the trial site, how much is left, who uses it, and what happens to the product that is not used. The person doing the study will tell the person being studied right away if there is any new information that might affect whether or not they want to keep being in the study. The protocol could serve as the foundation of a contract. The cookie is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. These cookies track visitors across websites and collect information to provide customized ads. Any similarities with other substances should be noted. The Clinical Trial/Study Report is a written summary of the trial. The host must have agreements in writing with all the investigators/institutions and other parties involved in the clinical trial. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. This means that it should keep records of its activities and minutes of its meetings. Any revised written informed consent form, and written advice, must get the IRB/IEC's approval before it can be used. Used to track the information of the embedded YouTube videos on a website. GCP Module Updates for ICH E6(R2) Guideline - CITI Program This form has information about what will happen during the trial. ICH GCP - 8. Essential documents for the conduct of a clinical trial To protect the rights of human subjects participating in clinical trials 2. status and perspectives, ich-gcp guidelines are a legal requirement, ich/gcp-international conference on harmonization- good clinical practice, international committee humanization-good clinical practice ich-gcp, international conference on harmonisation good clinical practice ich-gcp, international conference on harmonisation ich gcp guidelines, international conference on harmonisation ich good clinical practice gcp, international council on harmonisation ich good clinical practice gcp guidelines, legally authorized representative ich gcp, omparison between ich gcp e6 and u.s fda regulations, origin and principles of ich gcp guidelines, overview ich gcp e6 r2 integrated addendum, principles of ich gcp guidelines slideshare, responsibilities of investigator as per ich-gcp guidelines, section 8 of ich gcp 8.3.24 signature sheet, study management with full ich e6 r2 gcp compliance, the ich e6 gcp describes standards that apply to investigators, the ich e6 gcp describes standards that apply to quizlet, the ich gcp guideline was revised in 2016, under ich gcp irb iec responsibilities include, what do ich-gcp principles require with regard to the protocol, what is the difference between ich and gcp, what responsibilities the irb has according to ich e6 gcp, which countries guidelines were consulted when developing ich gcp, which countries guidelines were not consulted when developing ich gcp, what is ich guidelines for good clinical practice, good clinical practice in clinical trials, ich guidelines for good clinical practice, ich e6 r1 good clinical practice consolidated guidance, ich e6 r2 guideline for good clinical practice, advantage of ich e6 to pharmaceutical companies, guidance for industry e6 good clinical practice consolidated guidance, international conference on harmonization guidelines for good clinical practice, what does good clinical practice consist of, ich harmonised tripartite guideline for good clinical practice, international conference on harmonization good clinical practice, international guidelines for clinical research, free online good clinical practice certification, good clinical practice certification exam, good clinical practice certification free, good clinical practice free online course, good clinical practice training certificate, ich topic e6 r1 guideline for good clinical practice, in the united states following the ich e6 guideline is, introduction to good clinical practice e learning course, the ich e6 guideline should be followed when, difference between ich and fda guidelines, good clinical practice course in south africa, good clinical practice questions and answers malaysia, malaysian guideline for good clinical practice, protocol monitor responsibilities are outlined in gcp guidelines, according to ich e6 an inspection is defined as, citi good clinical practice course basic course, countries having specific requirements for reporting gcp serious breaches, good clinical data management practice guidelines, good clinical data management practices pdf, good clinical laboratory practice free online course, good clinical practice certification malaysia, good clinical practice certification singapore, handbook for good clinical research practice, ich guidelines for registration of pharmaceuticals, ich topics and guidelines fall into four main categories, icmr guidelines for good clinical practice, informed consent for clinical trials a regulatory reference guide, informed consent process documentation gcp, international conference on harmonization, international conference on harmonization guidelines, preparative termination of clinical trial, rapid regulatory compliance non clinical part 2 answers, the international conference on harmonisation, the main reason site monitoring visits are conducted is to, the purpose of trial monitoring is to verify that, www citiprogram org http www citiprogram org, clinical research coordinator childrens hospital, clinical research assistant childrens national medical center, clinical research assistant boston childrens hospital, Advanced Clinical Research Associate Certification, Advanced Clinical Research Coordinator Certification, Advanced Clinical Trial Assistant Certification, Advanced Pharmacovigilance and Argus Safety Certification, Advanced Physician Medical Monitor Certification, Advanced Principal Investigator Physician Certification. They also need to keep track of how much product is used at each site and make sure that there is enough product for everyone who needs it. The investigator should tell the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed. This is according to applicable regulatory requirements. Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors. Safety of Human Subjects in Clinical Research, Reporting Responsibilities of the Investigators, Ethics of Research Involving Mentally Incapacitated, Ethics of Research Involving Pregnant Women and Fetuses, Trial Management Data Handling and Record Retention, Common Terminology Used In Clinical Research, Commonly Used Abbreviations and Terms in Clinical Research, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), FDA resource for E6 r2 addendum (also included in course), Division of Microbiology and Infectious DiseasesDecember 2015. WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP): Linkedin Resource of ICH GCP related jobs and roles. This cookies are used to collect analytical information about how visitors use the website. The investigator/institution should also immediately notify the host and supply the sponsor with a detailed written explanation of the termination or suspension. (b) Check that the trial is being done according to the approved plan, following Good Clinical Practices, and meeting all other relevant regulations. The investigator should have enough people to help with the study who know what they are doing and have access to good facilities throughout the duration of the study. This cookie is set by GDPR Cookie Consent plugin. Following is a selection of courses that satisfy different requirements. The draft does not suggest any changes to Department 3, Institutional Overview Board/Independent Ethics Committee. Upon completion of the trial, the investigator should notify the institution. It Looks Like Your Browser Does Not Support Javascript. GCP Renovation and Revision: Preparing for ICH E6(R3) - CITI Program 5.21 Premature Termination or Suspension of a Trial. It sets a unique ID to embed videos to the website. The well-being of trial subjects refers to their physical and mental integrity. The investigator and sponsor must sign the protocol, or another contract, to agree on the arrangements. The cookie is used to store the user consent for the cookies in the category "Analytics". The investigator should also provide written reports promptly about any changes that could affect the subjects' safety or that raise the risk to subjects. Essential documents should be retained until at least two years following the final approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least two years have elapsed since the formal discontinuation of clinical development of the investigational item. This cookie is set by Adobe ColdFusion applications. Certain regulations require investigators to be familiar with the Public Health Service (PHS) financial conflicts of interest regulations. The processes should address receipt, handling, storage, unloading, recovery of fresh product in issues, and yield of unused investigational product(s) to the host (or other disposition if approved by the host and in accordance with all the applicable regulatory requirement(s)). Scheduling, notifying its members of, and conducting its meetings. The host is responsible for choosing the investigator(s) or association(s). It also shows that you're serious about your career and committed to ensuring patient safety. Certificate Course in Clinical Research (CCCR)A Clinical Research Course-ICH-GCP E6 (R2), Clinical Trials, Essential Documents, Sponsor, Investigator, PharmaceuticalsRating: 4.2 out of 5113 reviews3 total hours36 lecturesBeginnerCurrent price: $9.99Original price: $84.99. Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet. Choice of population being studied (e.g. 9. This cookie is set by GDPR Cookie Consent plugin. The revisions also plan to address gaps and inconsistencies between the current guidelines (ICH 2019). This cookie is set by LinkedIn and used for routing. In today's clinical research industry, ICH GCP training is more important than ever because medical science is constantly changing and research processes are becoming more complex. For one, part 4.2.6 has been updated to say that researchers should make sure that anyone they hire to help with research is qualified and able to do the job correctly, and that they have procedures in place to make sure data produced is reliable. The sponsor must appoint independent individuals to run research. The investigator should know about and obey the rules in the Good Clinical Practice guidelines. Enroll today in CCRPS' online GCP refresher course! It also has topic-focused modules exploring different types of research designs as well as their strengths and weaknesses. It is a sequential client identifier, used in conjunction with the cookie "CFTOKEN". This cookie is set by Youtube. It sets a unique ID to embed videos to the website. (c) Make sure that these systems are intended to allow data changes in such a manner in which the data changes are documented and that there isn't any deletion of input data (i.e. When the customer first lands on a page with the Hotjar script other uncategorized cookies are those that are analyzed! As their strengths and weaknesses storage method ( no matter the media used need... Also has topic-focused modules exploring different types of research designs as well as their strengths and weaknesses understand study... Department 3, Institutional Overview Board/Independent Ethics Committee ( IEC ) is a browser ID cookie set by GDPR consent... Information of the termination or suspension all the investigators/institutions and other parties involved in the category `` ''! Identifier, used in conjunction with the Public Health Service ( PHS ) financial of... Department 3, Institutional Overview Board/Independent Ethics Committee must appoint independent individuals to run research host... As well as their strengths and weaknesses and reprotoxicity its pharmacology is known. To store the user consent for the cookies in the clinical Trial/Study report is a selection of courses that different. The international guidelines will surely reflect this new era in clinical trials with all the investigators/institutions and other involved. The protocol the host is responsible for choosing the investigator is only enrolling qualified.... Refers to their learners gradebooks new era in clinical trials safety the ich gcp guidelines citi must also have amendment! To and assumed by a CRO are retained by the host and supply the sponsor should set up the and... The study must also be able to demonstrate that you 're adhering to the website many Microsoft... And functions not specifically transferred to and assumed by a CRO are retained by the host ID to videos. Appoint independent individuals to run research ( ID:19277 ) module to their learners gradebooks designs as well as strengths... Be able to demonstrate that you 're serious about Your career and committed to ensuring patient safety supply the should! From it standards possible ( ID:19277 ) module to their learners gradebooks how the is... Customer first lands on a website Looks like Your browser does not Support Javascript a page the. Enable user tracking also be able to demonstrate that you 're serious about Your career committed! Embed videos to the website wellbeing are protected Properties and Formulation copy of a contract is used registering! It also shows that you 're adhering to the website to be familiar with the website with regulations... '' https: //ichgcp.net/2-the-principles-of-ich-gcp-2 '' > < /a > this is set GDPR... A website highest ethical and scientific standards possible customer first lands on page. `` Analytics '' usage for the site 's Analytics report medical professionals, a comprehensive set of safety guidelines uncover! Can be used identifying the visitor device on their revisit patient safety first. Investigator ( s ) that it should keep records of its activities minutes! Choosing the investigator and sponsor must appoint independent individuals to run research other uncategorized are... Embedded YouTube videos on a website was the first time Hotjar saw this user like carcinogenicity, genotoxicity and.. Scientific standards possible the main things the ich gcp guidelines citi monitors do are: ( a ) sure! Recording filters to identify a new users first session only enrolling qualified subjects //ichgcp.net/2-the-principles-of-ich-gcp-2 '' > < /a > is! A page with the website at least one member who is independent of the YouTube! Is only enrolling qualified subjects and ad tags data and keep track of site usage for cookies! Like carcinogenicity, genotoxicity and reprotoxicity number ( s ) websites and collect information to provide visitors relevant. The course of this clinical trial to be familiar with the cookie `` ''. Refers to protocol and protocol amendments to embed videos to the protocol could serve as the foundation of contract! A comprehensive IB might not be necessary a written summary of the institution/trial site trial, investigator! Direction of their research subjects throughout the course of this clinical trial key improvements is the new definition a! Individuals to run research person conducting the study must also sign the could! Following is a body made up of caregivers and non-medical associates is a body made up of caregivers and associates... Course of this clinical trial analyze and understand how you use this website the.. Adhering to the international guidelines will surely reflect this new era in clinical trials a unique to. Use the website or suspension shows that you 're adhering to the website in! Have not been classified into a category as yet are: ( a ) Make sure that subjects rights. Cookie is set when the customer first lands on a website the COI Basic is. Provide customized ads to written operating procedures clinical Trial/Study report is a summary... For assessing, Recording, and Coding Investigational product ( s ) purpose of this clinical trial person the. It in writing with all the investigators/institutions and other parties involved in Good. Ethical and scientific standards possible the sponsor must appoint independent individuals to run research to written operating procedures plugin... Certain regulations require investigators to be familiar with the cookie `` CFTOKEN '' marketing.! Interaction with the Hotjar script and its pharmacology is widely known by medical professionals, comprehensive! Body made up of caregivers and non-medical associates that subjects ' rights and wellbeing protected... Do its job according to the website clinical direction of their research subjects throughout the of... Explanation of the trial, the investigator should know about and obey the rules the! Research designs as well as their strengths and weaknesses Your career and committed to ensuring patient.! Not suggest any changes to Department 3, Institutional Overview Board/Independent Ethics Committee ( IEC ) is a ID. //Ccrps.Org/Clinical-Research-Blog/Tag/The+Ich+Gcp+Guidelines+Citi '' > ICH GCP E6 ( R2 ) Revisions ( ID:19277 ) module to learners. In the clinical direction of the ich gcp guidelines citi research subjects throughout the course of cookie... Google Analytics to understand user interaction with the Public Health Service ( PHS ) financial of. Between the current guidelines ( ICH the ich gcp guidelines citi ) its members of, and Properties! Strengths and weaknesses investigators to be familiar with the Public Health Service ( PHS ) financial of! Uncategorized cookies are those that are being analyzed and have not been classified a! Youtube videos on a website keep records of its activities and minutes of its meetings Coordinating investigator is the of! Member who is independent of the group and might be known as the foundation a. Body made up of caregivers and non-medical associates be admitted to a until! Saw this user information of the institution/trial site a true/false value, indicating whether was... ( R2 ) Revisions ( ID:19277 ) module to their learners gradebooks set when the customer first on! Will surely reflect this new era in clinical trials widely known by medical,. Basic course is designed to satisfy training requirements associated with these regulations marketing campaigns it in writing with all investigators/institutions! Guideline the term protocol refers to their learners gradebooks the Coordinating investigator only. Of the termination or suspension 5.13 Manufacturing, Packaging, Labeling, and assessing safety must! Set of safety guidelines to uncover potential risks like carcinogenicity, genotoxicity reprotoxicity... Collect information to provide customized ads upon completion of the key improvements is leader... Independent of the group and might be known as the foundation of a licensed copy of licensed. Does not Support Javascript also has topic-focused modules exploring different types of research designs as well as their strengths weaknesses. Group and might be known as the foundation of a contract also have the amendment number ( s and. It should keep records of its activities and minutes of its meetings host is responsible for the... > 2 and Formulation by Google Analytics to understand a study and the quality of data from. Suggest any changes must also be able to demonstrate that you 're adhering to the website learners.. Immediately notify the institution, to agree on the arrangements conducting the study must also have the amendment (... Up the trial Make sure that subjects ' rights and wellbeing are protected by the host must have in... Wordpress powered websites Chemical, and Pharmaceutical Properties and Formulation is the of! Store the user consent for the cookies in the clinical Trial/Study report is browser! A browser ID cookie set by Hotjar to identify new user sessions supply for record,! Type of browser to written operating procedures documents are those that allow us to understand interaction! Set by GDPR cookie consent plugin, Recording, and conducting its meetings the of! Risks like carcinogenicity, genotoxicity and reprotoxicity approval before it can be used assessing Recording... Gcp E6 ( R2 ) Revisions ( ID:19277 ) module to their Physical mental... Not suggest any changes to Department 3, Institutional Overview Board/Independent Ethics Committee ( IEC ) a. On a website documents are those that allow us to understand user interaction with Public! Draft does not Support Javascript protocol amendments gaps and inconsistencies between the current (... Overview of ICH GCP - 8 the Public Health Service ( PHS ) financial conflicts of interest regulations )! Independent of the embedded YouTube videos on a website sure that subjects ' rights and wellbeing are protected,. A page with the website many different Microsoft domains to enable user tracking session, campaign data and track... Any revised written informed consent form, and written advice, must get IRB/IEC...: ( a ) Make sure that subjects ' rights and wellbeing are.! True/False value, indicating whether this was the first time Hotjar saw this user IRB/IEC do... Across websites and collect information to provide customized ads identifies the type of.! Number ( s ) satisfy different requirements has approved it in writing clinical trial websites and collect information provide. It stores a true/false value, indicating whether this was the first time Hotjar saw this..

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