CTFG guideline Recommendations related to contraception and pregnancy testing in clinical trials

Recommendations related to contraception and pregnancy testing in clinical trials Introduction and scope The aim of this document is to supplement existing guidelines related to embryofetal risk mitigation and to provide practical guidance on contraception use and pregnancy testing in clinical trials. It is not the aim of this document to discuss when women of childbearin The measures mandated by the protocol must comply with the IB recommendations or the SmPC requirements. Recommendations related to contraception and pregnancy testing in clinical trials have been.. The CTFG inform the Sponsors that the Voluntary Harmonization Procedure (VHP) project will be closed contextually with the implementation of the EU regulation 536/2014 on clinical trials. Sponsors are therefore informed that, starting 60 days before the effective date of the new regulation, initial clinical trial applications and substantial modifications applications via VHP will no longer be accepted and processed by the VHP administrator Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (CT-3) Clinical Trial..

Clinical trial facilitation group (CTFG): recommendations related to contraception and pregnancy testing in clinical trials [3] The CTFG supports the Heads of Medicines Agencies, a network of the heads of the National Competent Author-ities whose organizations are responsible for the regula-tion of medicinal products for human and veterinary us The Clinical Trial Facilitation Group (CTFG) has issued a 'Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials' (publication date: 12 February 2019). This document provides recommendations for sponsors regarding the authorisation and conduct of complex clinical trials. It describes the current perspective of the Clinical Trials Facilitation and Co-Ordination Group (CTFG) on these trials and outlines the major issues that sponsors should address in the. Recommendations for Pregnancy Testing in Clinical Trials July 2017 CTTI MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials Clinical Trials Transformation Initiative. Recommendations for pregnancy testing in clinical trials Clinical Research units. For Covance guidance purposes, the general recommendation is to consider all WOCBP as those practicing typical use for a given BCM. Definitions Women of Child-Bearing Potential (WOCBP): premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.1,6-7 For typical Covance early Phase I/ Phase Ib clinical trials, WOCBP will include healthy women at least 18 years old Initial pregnancy testing prior to participation in the clinical trial and, where necessary and appropriate, study entry only after a confirmed menstrual period. If pregnancy is confirmed prior to the start of the trial in general, the subject should not be enrolled in the trial. Exceptions may be considered on a case by case basis (e.g. cancer patients fully informed about the foetal risks.

Common issues: Clinical - GOV

  1. Clinical Trial Facilitation Group (CTFG) In 2004 the Heads of Medicines Agencies (HMA) agreed to establish a clinical trials facilitation group (CTFG) to coordinate the implementation of the EU clinical trials directive 2001/20 EC across the member states. The CTFG consists of clinical trials professionals from the EU/EEA Medicines Agencies (NCAs)
  2. istration (FDA) regarding assessment of male-mediated developmental.
  3. If the PI or IB specifies pregnancy testing requirements, contraception requirements or other limitations for use in men or women of reproductive potential, these stipulations must be used by the investigator in the design of the clinical trial and the protocol document. If data are lacking i
  4. Guidance documents accessible from this page represent the Agency's current thinking on the conduct of clinical trials/good clinical practice (GCP) and human subject protection (HSP)
  5. Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials . Guidance for Industry . DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only
  6. Examples of standardized texts are given for recommendations on the use during pregnancy and lactation. 1 INTRODUCTION AND BACKGROUND The information and advice given on how to use a medicinal product in relation to human reproduction should allow a physician to manage a number of situations. These situations include prescription of medicinal products to women of child-bearing potential.

Recommendations related to contraception and pregnancy testing in clinical trials. Advisory non-binding guidance supported by national competent authorities represented at the CTFG-meeting in Rome 2014-09-15. 2014. Google Schola CTTI's recommendations can help research sponsors, investigators, and institutional review boards create and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials The clinical trial program of a medicinal product under development rarely includes pregnant women, products authorised for pregnancy-related symptoms and disorders or pro-fertility drugs. Other products like herbal medicines and the use of medicinal products during breast-feeding are not covered either in this guideline. 1.3 Legal basis This guideline should be read in conjunction with.

Guidance outlines strategies to identify and mitigate risks for trial participants. The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial participants.. First-in-human trials are a key step in medicines development, where a medicine already tested in vitro, in animals or in other. The purpose of the CTFG recommendations document is to supplement existing guidelines related to embryofetal risk mitigation and to provide practical guidance on contraception use and pregnancy testing in clinical trials. The guideline applies to al

Heads of Medicines Agencies: Clinical Trials Facilitation

Useful Resources - GOV

EudraLex - Volume 10 - Clinical trials guidelines. Volume 10 of the publication The rules governing medicinal products in the European Union contains guidance documents applying to clinical trials. A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation. FDA issues draft guidance regarding clinical trials to establish effectiveness and safety for hormonal contraceptives intended to prevent pregnancy

Regulations, Guidance, and Reports related to Women's Health. FDA has been committed to addressing women's health since its inception in 1906, as illustrated by events in its history, such as. The recommendations in this report are intended to serve as a source of clinical guidance for health care providers and provide evidence-based guidance to reduce medical barriers to contraception access and use. Health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for.

This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. It also advises how these changes should be communicated to authorities. There is specific advice on the initiation of new clinical trials for treatments of COVID-19, and in particular on the. WHO guideline recommendations on digital interventions for health system strengthening. for behaviour change related to sexual, reproductive, maternal, newborn, child and adolescent health. 56. page . iv. 3.7. Effective coverage: Health worker decision support. 63 3.8. Multiple points of coverage: Digital tracking of clients' health status and services . combined with decision-support.

'CTFG': Recommendation Paper on the Initiation and Conduct

Clinical Recommendations by Topic. The AAFP equips you with the data, knowledge, competencies and skills to provide high quality, evidence-based care of your patients in the context of family and. The updated recommendations to the WHO guideline, Medical eligibility criteria for contraceptive use, stem from a review of the latest evidence conducted by the independent Guideline Development Group convened to inform WHO. This Group assessed all of the evidence on hormonal contraception and risk of HIV acquisition published since the previous review published in 2016, along with a. Many of these recommendations include guidance that a woman can start a contraceptive method at any time during her menstrual cycle if it is reasonably certain that the woman is not pregnant. Guidance for health-care providers on how to be reasonably certain that a woman is not pregnant is provided. For each contraceptive method, recommendations include the examinations and tests needed before. Guidance includes recommendations from FSRH's guidance on contraception for women using known teratogenic drugs or drugs with potential teratogenic effects published in February 2018. Some medicines are known or suspected to have the potential to increase the risk of birth defects and development disorders (teratogenic potential) when taken during pregnancy, especially during the first. A detailed review of the European regulatory authorities' recommendations related to contraception and pregnancy testing in clinical trials has been made by the Clinical Trials Facilitation Group (CTFG). We recommend that you keep updated about the recommendations of the CTFG. The following is an overall description of the recommendations of the CTFG. Where relevant, it must be clearly.

Published on: 1 October 2020 File size: 1566kb PDF File type: Current Clinical Guidance Contraception After Pregnancy, endorsed by the Royal Colleges: GPs; Obstetricians and Gynaecologists; Nurses and Midwives, aims to guide healthcare professionals to inform and support the women in their care to make planned choices about future pregnancies and improve maternal and child outcomes through. The recommendations of this revised guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the regions of European Union (EU), Japan, and the United States. The present guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human. The College's clinical guidance, and a pregnancy test should be repeated in 2-4 weeks. If there is uncertainty about pregnancy, an IUD should not be inserted until the health care provider is reasonably certain that the patient is not pregnant. Additional information about initiating specific contraceptive methods and use of back up contraception is available in the CDC's U.S.

Clinical trials authorization requests - submission letters. Please be informed that new models of letters to submit requests for authorizations of clinical trials and amendments are available; this update derives from the restoration of the National Monitoring Centre on Clinical Trials of Drugs (OsSC), in accordance with the provisions in force since October 1, 2014, published on the AIFA. estradiol-containing combined oral contraceptives after pregnancy Faculty of Sexual & Reproductive Healthcare (FSRH) provided funding to the Clinical Effectiveness Unit (of the FSRH) to assist them in the production of this guideline, Contraception After Pregnancy (January 2017, amended October 2020) CTFG 21/09/2020 Version 1.1 1 Recommendations related to contraception and pregnancy testing in clinical trials Version 1.1 Introduction and scope The aim of this document is to supplement existing guidelines related to embryofetal risk mitigation and to provide practical guidance on contraception use and pregnancy testing in clinical trials These recommendations are meant to serve as a source of clinical guidance for health care providers; health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients, who should seek advice from their health care providers.

WHO launches new guideline to help health-care workers ensure safe medical abortion care. 8 January 2019: When women and girls can access effective contraception and safe abortion services, they are better able to safeguard their health and well-being.. Abortions are safe if they are done with a WHO-recommended method that is appropriate to the pregnancy duration, and if the person providing. UK MHRA. Recommendations related to contraception and pregnancy testing in clinical trials. Advisory non-binding guidance supported by national competent authorities represented at the CTFG-meeting in Rome 2014-09-15. 2014. 5. World Health Organization WHO clinical guidelines 13 October 2017; Assessing and managing children at primary health-care facilities to prevent overweight and obesity in the context of the double burden of malnutrition Updates for the integrated management of childhood illness (IMCI) - Guideline 3 October 2017; WHO guideline on syphilis screening and treatment for pregnant women 3 October 2017; Integrated care for.

professionals providing contraceptive services to young people. Recommendations are based on available evidence and consensus opinion of experts. They should be used to guide clinical practice but they are not intended to s erve alone as a standard of medical care or to replace clinical judgement in the management of individual cases. A key to. Guideline Development. The HRSA-supported Women's Preventive Services Guidelines were originally established in 2011 based on recommendations from a Department of Health and Human Services' commissioned study by the Institute of Medicine (IOM), now known as the National Academy of Medicine (NAM). Since then, there have been advancements in science and gaps identified in the existing.

File type: Current Clinical Guidance. Author: FSRH Clinical Effectiveness Unit. This update of the 2010 Contraception for Women Aged Over 40 Years guideline has been developed by the FSRH and brings together evidence and expert opinion on contraception for women aged over 40 years. The guideline was developed with a team of experts in the. After the 4-week trial, continue THC:CBD spray if the person has had at least a 20% reduction in spasticity-related symptoms on a 0 to 10 patient-reported numeric rating scale. 1.3.2 Treatment with THC:CBD spray should be initiated and supervised by a physician with specialist expertise in treating spasticity due to multiple sclerosis, in line with its marketing authorisation Additionally, pregnancy testing at baseline only is not deemed sufficient and must be repeated more frequently, at least if clinical signs of pregnancy occur and at follow-up / end of study. male participants, if vasectomized or not, must wear a condom each time having heterosexual intercourse throughout the period of relevant systemic exposure with Favipiravir (as it is distributed to seminal. This collection features AFP content on family planning and contraception, including emergency contraception, hormonal and non-hormonal contraception, infertility, in vitro fertilization. Long-acting reversible contraceptives are the most effective methods to prevent pregnancy and also offer noncontraceptive benefits such as reducing menstrual blood flow and dysmenorrhea. The safety and efficacy of long-acting reversible contraception are well established for adolescents, but the rate of use remains low for this population

ICH Guidelines: Inception, Revision, and guidances released by the International Council for Harmonisation [ICH] the Clinical Trial Facilitation Group [CTFG] and the US Food & Drug Administration [FDA]. Methods Relevant aspects of the new guidance documents are discussed in the context of male contraception and pregnancy reporting from female partner in clinical trials and the approach is. Contact. For information about your submission, including status and tracking enquiries, contact the clinical trials helpline on 020 3080 6456 (Monday to Friday 8:30am to 4.30pm) or email.

Pregnant individuals were not included in clinical trials of any of the vaccines currently available under EUA, but studies are underway. While limited safety data specific to use of COVID-19 vaccines in pregnancy are available, to date there are no data to indicate that the vaccines should be contraindicated, and no safety signals were generated from DART studies for the Pfizer-BioNtech. first tri mester is especially important. This guideline presents a chronological sequence of prenatal care that is based on scientific evidence, recommendations of the US Public Health Service, clinical judgment regarding effectiveness of identifying and modifying risk, and the success of medical and psychosocial interventions Clinical recommendation Evidence rating Reference; Ask women of reproductive age about intention to become pregnant. Provide contraceptive counseling tailored to patients' intentions. C. 1, 2. New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested. The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people.

WHO guidelines. The development of global guidelines ensuring the appropriate use of evidence represents one of the core functions of WHO. A WHO guideline is defined broadly as any information product developed by WHO that contains recommendations for clinical practice or public health policy. Recommendations are statements designed to help end. ESC Clinical Practice Guidelines aim to present all the relevant evidence to help physicians weigh the benefits and risks of a particular diagnostic or therapeutic procedure on Cardiovascular Diseases during Pregnancy. They should be essential in everyday clinical decision making Contraception p4 Teenage pregnancy and abortion rates have fallen in the past decade. This section highlights NICE guidance on contraception and how it can help to prevent unwanted pregnancies. Sexually transmitted infections p9 Sexually transmitted infection rates have stabilised over recent years though recent trends show that some infections are increasing. This section reviews how NICE. Clinical recommendation Evidence rating References; Nulliparous women and adolescents can be offered an IUD, although the 20-mcg per 24 hours levonorgestrel-releasing IUD (Mirena) is not approved.

Guidance Document: Considerations for Inclusion of Women

These Guidelines do not provide for or support the requirement of coverage or payments for contraceptive services with respect to individuals who object as specified in this paragraph (I)(b), and nothing in 45 CFR 147.130(a)(1)(iv), 26 CFR 54.9815-2713(a) (1)(iv), or 29 CFR 2590.715-2713(a)(1)(iv) may be construed to prevent a willing health insurance issuer offering group or individual. The recommendations in these Guidelines have been endorsed by the National Health and Medical Research Council as meeting the Council's standards for the preparation of evidence-based recommendations. We commend this latest edition of the Pregnancy Guidelines, a process that started in 2008 and is continuing in 2018 with the support of the Department of Health with the preparation of.

Clinical Trial Facilitation Group (CTFG) CTFG/VHP

of recent findings from clinical trials confirming that the early use of ART keeps people living with HIV alive and healthier and reduces the risk of transmitting the virus to their sexual and drug-sharing partners. Earlier treatment has the further advantage of simplifying the operational demands on programmes. Additional recommendations in the guidelines aim to help programmes deliver. The 97 recommendations presented in the new Guidelines help define current best practices for thyroid function testing, iodine nutrition, pregnancy complications, and treatment of thyroid disease during pregnancy and lactation. The American Thyroid Association (ATA) guidelines are available free on the website of Thyroid, the official peer-reviewed journal of the ATA, published by Mary Ann. Guidelines are developed using clinically relevant questions, which are then answered by systematic reviews of the literature, and followed by data-supported recommendations. Practice Guidances AASLD practice guidances are developed by a panel of experts on a topic, and guidance statements are put forward to help clinicians understand and implement the most recent evidence The USPSTF recommends repeated Rh(D) antibody testing for all unsensitized Rh(D)-negative women at 24 to 28 weeks' gestation, unless the biological father is known to be Rh(D)-negative. B: February 2004 * Rh(D) Incompatibility: Screening: pregnant women, during the first pregnancy-related care visi Guideline Clinical App gives you access clinical guideline content, guideline recommendations, 10 Points summaries, and tools such as risk scores and calculators. Tip: After submitting key term, narrow your results by filtering by clinical topic or selecting specific document types. 2021

Clinical trial considerations on male contraception and

Physical activity and sedentary behaviour guidelines - pregnancy - brochure. NA0119. Summary by age Children and young people Recommendations. Under 12 months. 1 to 2 years. 3 to 5 years. 5 to 17 years. Physical activity . Interactive floor-based play, and at least 30 minutes of tummy time for babies per day. At least 3 hours of energetic play per day. At least 3 hours per day, with 1 hour. Recommendation Topics. The U.S. Preventive Services Task Force is an independent panel of experts in primary care and prevention that systematically reviews the evidence of effectiveness and develops recommendations for clinical preventive services. These reviews are published as U.S. Preventive Services Task Force recommendations on the Task. Recommendations. The specific recommendations in the 2019 Canadian Guideline for Physical Activity throughout Pregnancy are provided below with corresponding statements indicating the quality of the evidence informing the recommendations and the strength of the recommendations (explanations follow).. 1. All women without contraindication should be physically active throughout pregnancy Clinical Care Guidelines. To ensure that people with CF continue to experience steady gains in length and quality of life, the Foundation helps its accredited care centers provide a standard of CF care with guidelines. We base guidelines on the latest research, medical evidence, and consultation with experts on best practices Published Recommendations. Recommendations present relevant evidence to help health professionals in rheumatology weigh the benefits and risks of a particular diagnostic or therapeutic procedure. Classification and diagnosis criteria/response criteria. Recommendations for conducting/reporting clinical trials. Recommendations for management

Clinical Trials Guidance Documents FD

Nearly 100 fact sheets on a wide array of cancer topics. Fact sheets address risk factors, prevention, support, treatment, and more For patients with unprovoked DVT and/or PE, the ASH guideline panel suggests against routine use of prognostic scores (recommendation 15), D-dimer testing (recommendation 16), or ultrasound to detect residual vein thrombosis (recommendation 17) to guide the duration of anticoagulation (conditional recommendations based on very low certainty in the evidence of effects ⨁ )

Pregnant Women: Scientific and Ethical Considerations for

Will a pregnancy test work if I'm on the pill? Other methods of contraception prevent pregnancy, but they do not protect against STIs. Answer the questions on this page to help you decide which method is most suitable for you. Contraception choices tool. The Contraception choices tool can help you find out which methods of contraception: may be best for you; are most effective at. Clinical guidelines Diagnosis and treatment manual for curative programmes in hospitals and dispensaries guidance for prescribing 2013 EDITION . Pieterson Badoa. Download PDF. Download Full PDF Package. This paper. A short summary of this paper. 30 Full PDFs related to this paper. READ PAPER. Clinical guidelines Diagnosis and treatment manual for curative programmes in hospitals and. Pregnancy always must be assessed using an acceptable pregnancy test. While menstrual and contraceptive history may be useful, the assessment of pregnancy status should not be made solely by self-reported information. As with all research, investigators and IRBs must adhere to the additional requirements pertaining to research involving fetuses, pregnant women, and human in vitro fertilization.

Guidelines Publication Schedule. ESC Clinical Practice Guidelines and scientific statements are prepared by task forces which are groups of cardiologists that meet upon request to deal with particular problems in cardiology. Published in 2020. Non-St-Segment Elevation Acute Coronary Syndromes. Atrial Fibrillation. Adult Congenital Heart Disease Objective: To improve awareness of the natural age-related decline in female and male fertility with respect to natural fertility and assisted reproductive technologies (ART) and provide recommendations for their management, and to review investigations in the assessment of ovarian aging. Options: This guideline reviews options for the assessment of ovarian reserve and fertility treatments. Guideline Implementation Tools and Resources ASH Clinical Practice Guidelines App. The ASH Clinical Practice Guidelines App provides easy access to every recommendation from all guidelines published by ASH, including rationale for each recommendation, benefits and harms associated with each recommended course of action, and links to the complete evidence-to-decision tables used to develop the. Diagnosis/testing: Factor V Leiden thrombophilia is suspected in individuals with a history of venous thromboembolism (VTE) manifest as deep vein thrombosis (DVT) or pulmonary embolism, especially in women with a history of VTE during pregnancy or in association with use of estrogen-containing contraceptives, and in individuals with a personal or family history of recurrent thrombosis In August 2002, a new federal rule took effect that protects the privacy of individuals' health information and medical records.1 The rule, which is based on requirements contained in the Health Insurance Portability and Accountability Act of 1996 (HIPAA), embodies important protections for minors, along with a significant degree of deference to other laws (both state an Guidelines and Measures provides users a place to find information about AHRQ's legacy guidelines and measures clearinghouses, National Guideline Clearinghouse (NGC) and National Quality Measures Clearinghouse (NQMC

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