Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)
The Data Safety and Monitoring Board (DSMB) or Data Monitoring Committee (DMC – these are synonymous terms) is a group of individuals put together by the sponsor or CRO (if contracted out) with relevant expertise to carry out the important role of monitoring the safety of a clinical trial study.
A prospective, qualitative, multi-site study investigating the barriers and enablers to locally-led clinical trial conduct in Ethiopia, Cameroon, and Sri Lanka; here the protocol, methods and instroduction are available for readers.
A code of ethics created by the San people of Africa for researchers wishing to study their culture.
This paper proposes a generic ordinal sequential trial design (GOST) for a randomised clinical trial comparing an experimental treatment for an emerging infectious disease with standard care. The design is intended as an off-the-shelf, ready-to-use robust and flexible option. This article was first published in PLOS.
The World Health Organization Fetal Growth Charts: A Multinational Longitudinal Study of Ultrasound Biometric Measurements and Estimated Fetal Weightby Kiserud et al
WHO made it a high priority to provide the present fetal growth charts for estimated fetal weight (EFW) and common ultrasound biometric measurements intended for worldwide use. This study provides WHO fetal growth charts for EFW and common ultrasound biometric measurements, and shows variation between different parts of the world.
There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.
Epidemic curves are an important component of the public health and global health toolbox. Learn more about creating and interpretting them.
The following invitation to take part in trials methodology research comes from the Network of Hubs for Trials Methodology Research (HTMR) which was established by the UK Medical Research Council (MRC) to improve the quality of clinical trials.
The TDR Global Competency Framework for Clinical Research: a set of tools to help develop clinical researchersby TDR, The Global Health Network
The TDR Global Competency Framework for Clinical Research is a flexible framework which lists all the competencies that should be demonstrated by a research team to carry out a successful clinical study. It can be used for any research study, regardless of the size of the team and of the study itself. It can help to plan the staffing requirements for a study, to help carry out appraisals of staff, to help individuals plan their career development, and to help to develop educational curricula for research staff.
Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness is required to ensure the benefits outweigh any harms. Read this article to find out more and download some of the safety tools developed by experts from the Malaria in Pregnancy Consortium.
A guide to developmental evaluation.
Introduction to one-stop site for evaluation of community sustainability engagement projects.
An introduction to the Manchester University (UK) Guide to evaluating engagement.
Introduction to RCUK's Evaluation of Engagement guide.
This paper proposes an ethical framework for Community Engagement. The framework is grounded in the insight that relationships between the researcher and the community extend beyond the normal bounds of the researcher-research participant encounter and are the foundation of meaningful engagement.
HOW TO COLLABORATE? Applicants with research interests relevant to CoLab (complications of pregnancy) may apply to collaborate with CoLab. Please note that to obtain samples and/or data from CoLab cohorts, you will need a member of CoLab to be your sponsor. We can help assist you in getting a sponsor. All CoLab projects are considered collaborations and you will work directly with CoLab members and cohorts to obtain data and/or biological samples for your project. However, you will work directly with the CoLab office thorough the application process, to give quarterly updates, and to work with a protocol committee regarding your project.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
U.S. efforts to combat the Zika virus in the US and abroad
Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.
Strategy for Standardization of Preeclampsia Research Study Design
This glossary provides definitions of some common terms encountered in clinical research.
Greg Martin talks about four areas of competencies needed to be effective in public health and global health. He places particular importance on management, leadership and governance.
The INTERGROWTH-21st global references and z scores for head circumference, length and weight at birth of very preterm newborns are available to download below.
New INTERGROWTH-21st very preterm size at birth reference charts have been published in The Lancet.
With Zika infection rates now seeming to be on the increase, the Oxford Science Blog talked to Professor Lang about why it is so important to develop capacity for doing research in places where research doesn't normally happen.
This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. The paper was published in Clinical Trials.
Reporting missing participant data in randomised trials: systematic survey of the methodological literature and a proposed guideby Akl et al 2016
Authors conducted a systematic survey of the methodological literature to identify recommended approaches for how and what randomised clinical trial (RCT) authors should report on missing participant data and, on the basis of these approaches, to propose guidance for RCT authors. Most identified approaches invite trial authors to report the extent of MPD and the underlying reasons. Fewer approaches focus on reporting missingness patterns, methods for handling MPD and implications of MPD on results.
Looking for a job in global health? A 4 part series that takes a look at what you need to do to get your career in global health off to a good start.
eSeminar: Research papers that make a difference: discussing research waste, reproducibility and impactby Iveta Simera, the EQUATOR Network
Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.
New articles from the African Society for Laboratory Medicine (ASLM).
New INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants - Charts availableby INTERGROWTH-21st
New INTERGROWTH-21st Postnatal Growth Standards charts for individual measurements of length, weight, head circumference, as well as a combined standards chart for length, weight and head circumference are now available for download here.
Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
The first international stnadards for monitroing the growth of preterm babies have now been published in the Lancet Global Health (October 2015).
Scientific title: Infectious disease aetiologies of uncomplicated febrile illness in children <5 years of age in rural Zanzibar. As a result, Zanzibar has turned into a low transmission area with a decline of P. falciparum malaria among children with fever from approximately 30% to 1%, as well as a significant reduction of the crude child mortality.
Scientific title: Effectiveness of Malaria Rapid Diagnostic Tests in fever patients attending primary health care facilities in Zanzibar. Over the past decade, Zanzibar has adopted artemisinin-based combination therapy (ACT), long lasting insecticide treated nets and indoor residual spraying
Strategies for expanding access to quality malaria diagnosis in south-central Asia where malaria incidence is lowby ACTConsortium
Scientific title: An examination of ACT strategy in south-central Asia on P. falciparum malaria in a context where P. vivax is the major species. With the exception of Sub-Saharan Africa, most areas that are endemic for malaria have a combination of two species: Plasmodium falciparum and P. vivax. P. vivax is often the dominant species, accounting for a greater proportion of malaria cases.
Scientific title: A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria. Private-sector providers are a major source of malaria treatment in Nigeria, and many patients in Enugu state seek treatment at pharmacies and drug stores as well as public health centres.
Training manuals from REACT study in Cameroon. REACT Cameroon designed six training modules to support the introduction of malaria rapid diagnostic tests (RDTs). The manuals were used to train health workers at government and mission hospitals and health centres. The six modules are presented in two manuals
New INTERGROWTH-21st Fetal Growth Standards charts for measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download.
Improving Clinical Research Data: The Understanding and Implementation of Laboratory Quality Management System (LQMS)by Augustine Onyeaghala. MSc, PhD, MSQA, PGDQA, FMLSCN
This article provides a helpful introduction to statistics as it relates to clinical research, explaining common terms and theories with examples and case studies. Powerpoint presentation also attached for further explanation.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
Grant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.
In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.
Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.
In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.
Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked.
Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.
In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.
This article published in PLOS Medicine on April 14th, 2015 discusses how best to test Ebola treatment.
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact email@example.com.
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.
Global standards and z scores for length at birth, with information related to their use. Online calculators will be available shortly.
Global standards and z scores for head circumference at birth, with information related to their use. Online calculators will be available shortly.
Global standards and z scores for birth weight at birth, with information related to their use. Online calculators will be available shortly.
The ISARIC-WHO Clinical Characterisation Protocol for Severe Emerging Infection, with supporting documents. Under WHO ERB review.
Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.
International standards for newborn weight, length, and head circumference by gestational age and sex: the Newborn Cross-Sectional Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
These international anthropometric standards were developed to assess newborn size in routine clinical practice that are intended to complement the WHO Child Growth Standards and allow comparisons across multiethnic populations.
International standards for fetal growth based on serial ultrasound measurements: the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
Using the same methods and conceptual approach as the WHO child growth standards, the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project developed international growth and size standards for fetuses for clinical interpretation of routinely taken ultrasound measurements and for comparisons across populations.
Seven principles for strengthening research capacity in low- and middle-income countries: simple ideas in a complex worldby ESSENCE on Health Research Initiative
This good practice document of the ESSENCE on Health Research initiative is designed to provide broad guidance on how best to strengthen research capacity with the maximum possible benefit.
Translating research into practice: the introduction of the INTERGROWTH-21st package of clinical standards, tools and guidelines into policies, programmes and servicesby INTERGROWTH-21st
This paper describes the approach to translating the findings, tools and resources generated by the INTERGROWTH-21st Project into practice. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12416/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Seattle, USA. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12126/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Oxford, UK. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12033/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Muscat, Oman. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12043/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nairobi, Kenya. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12045/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Turin, Italy. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12124/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nagpur, India. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12058/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Beijing, China. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12044/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Pelotas, Brazil. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12046/abstract
The INTERGROWTH-21st Project presented a complex set of ethical challenges given the involvement of health institutions in geographically and culturally diverse areas of the world, with differing attitudes to pregnancy. This paper addresses how the research team dealt with some of those issues. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12030/abstract
Statistical considerations for the development of prescriptive fetal and newborn growth standards in the INTERGROWTH-21st Projectby INTERGROWTH-21st
This paper considers the statistical aspects of the three components of the INTERGROWTH-21st Project - the Fetal Growth Longitudinal Study, the Preterm Postnatal Follow-up Study, and the Newborn Corss-Sectional Study - as they relate to the construction of the INTERGROWTH-21st standards, in particular, the sample size. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12031/abstract
Given the multicentre nature of the INTERGROWTH-21st Project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21st Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21st participating centres. Thoughts about implementation strategies are presented. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12312/abstract
Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Projectby INTERGROWTH-21st
The INTERGROWTH-21st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12127/abstract
Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Projectby INTERGROWTH-21st
Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21st Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this standardisation, training and quality control process. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.
A unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21st Project. These standardised methods should minimise the systematic errors associated with pooling data from different sites. They represent a model for carrying out similar research studies in the future. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12313/abstract
This paper outlines the objectives, design and implementation of the INTERGROWTH-21st Project, a multicentre, multiethnic, population-based project conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from pregnancy to early infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12047/abstract
Professor Sir Sabaratnam Arulkumaran, President of FIGO, introduces the methods of the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12314/abstract
Identify, assess, report, and follow serious adverse events occurring in study patients enrolled in an antimalarial drug efficacy trial.
This study protocol descibes the the objectives, design and implementation of the Fetal Growth Longitudinal Study (FGLS), the Preterm Postnatal Followup Study (PPFS), and the Newborn Cross Sectional Study (NCSS). Data from these studies inform new, international fetal and newborn growth standards and a package of accompanying resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/Intergrowth%20Protocol%20Sept%202009.pdf
This operation manual was used to implement the Fetal Growth Longitudinal Study (FGLS), which involved screening healthy women between 9 and 14 weeks gestation at the time of their early antenatal visit, and followed-up with standard clinical and 2D ultrasound examinations every 5 weeks, i.e. up to six times during a term pregnancy. The results of the FGLS inform new, international fetal and newborn growth standards and a package of supportive tools, guidelines and resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/FGLS%20Manual%2015-09.pdf
This resource was used to train health professionals on how to record key data on pregnancies and deliveries for women participating in the Fetal Growth Longitudinal Study (FGLS) and Newborn Cross Sectional Study (NCSS). http://www.medscinet.net/Intergrowth/patientinfodocs/Pregnancy%20and%20Delivery%20Form%20Instructions.pdf
The INTERGROWTH-21st Project used this manual to standardize definitions, treatment and management recommendations of neonatal morbidities. http://www.medscinet.net/Intergrowth/patientinfodocs/Neonatal%20Manual%20Final.pdf
This handbook describes the methods used to perform accurate, precise and standardized anthropometric measurements for all components of the INTERGROWTH-21st study, including:
- height and weight of pregnant mothers
- birth weight, length and head circumference of newborns
- weight, length and head circumference of preterm babies
This protocol outlines the technique for measuring symphysis fundus height. http://www.medscinet.net/Intergrowth/patientinfodocs/Measurement%20of%20Symphysis%20Fundus%20Height.pdf
This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf
The aims of this manual are to ensure all trained ultrasonographers are familiar with the standardized way measurements should be taken for the purposes of using the INTERGROWTH-21st growth standards, including standardization of the way the equipment should be used, ultrasound findings are recorded, data is entered and transfered, and how to train, asesses and certify these standardized techniques. http://www.medscinet.net/Intergrowth/patientinfodocs/US%20Manual%20FINAL.pdf
The aim of this manual is to ensure all trained ultrasonographers are familiar with the standardized way crown-rump length measurements should be taken for the purposes of using the INTERGROWTH-21st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf
This manual details the technique for assessing sleep-wake cycles in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Sleep-wake%20cycle%20assessment%20manual%20July%202014.pdf
The basic requirements for new sites wanting to take part in clinical research - What sites need to know!by Caroline Sibeko
Article looks at the risk of dengue fever outbreaks in southern Europe as temperatures increase. Abstract Background Dengue fever is the most prevalent mosquito-borne viral disease worldwide. Dengue transmission is critically dependent on climatic factors and there is much concern as to whether climate change would spread the disease to areas currently unaffected. The occurrence of autochthonous infections in Croatia and France in 2010 has raised concerns about a potential re-emergence of dengue in Europe. The objective of this study is to estimate dengue risk in Europe under climate change scenarios. Methods We used a Generalized Additive Model (GAM) to estimate dengue fever risk as a function of climatic variables (maximum temperature, minimum temperature, precipitation, humidity) and socioeconomic factors (population density, urbanisation, GDP per capita and population size), under contemporary conditions (1985–2007) in Mexico. We then used our model estimates to project dengue incidence under baseline conditions (1961–1990) and three climate change scenarios: short-term 2011–2040, medium-term 2041–2070 and long-term 2071–2100 across Europe. The model was used to calculate average number of yearly dengue cases at a spatial resolution of 10 × 10 km grid covering all land surface of the currently 27 EU member states. To our knowledge, this is the first attempt to model dengue fever risk in Europe in terms of disease occurrence rather than mosquito presence. Results The results were presented using Geographical Information System (GIS) and allowed identification of areas at high risk. Dengue fever hot spots were clustered around the coastal areas of the Mediterranean and Adriatic seas and the Po Valley in northern Italy. Conclusions This risk assessment study is likely to be a valuable tool assisting effective and targeted adaptation responses to reduce the likely increased burden of dengue fever in a warmer world.
ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs.
The authors present the story of building a succesful research laboratory in Cameroon, including how they managed building up the infrastructure, equipment maintenance, staff training.
Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.
Despite published guidance on writing the abstract in the PRISMA Statement guiding the reporting of systematic reviews in general and elsewhere, evaluations show that reporting of systematic reviews in journal and conference abstracts is poor. Teh authors developed consensus-based reporting guidelines as an extension to the PRISMA Statement on good reporting of systematic reviews and meta-analyses in abstracts.
Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.
A sample plan for sample collection with regards to a potential novel coronavirus outbreak, developed by Kenneth Baillie and ISARIC's Working Group 3.
Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:
- CONSORT Statement (reporting of randomized controlled trials)
- STARD (reporting of diagnostic accuracy studies)
- STROBE (reporting of observational studies in epidemiology)
- PRISMA (reporting of systematic reviews)
- MOOSE (reporting of meta-analyses of observational studies)
Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.
It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.
During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.
Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.
Considerations for pharmacovigilance and safety reporting.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.