Protocol Submission Please complete the form below to submit your protocol to the Scientific Committee of ISLS. Please complete the form below to submit your protocol to the Scientific Committee of ISLS. You may download a paper version of this form in Word format. Primary Investigator Salutation, full name and degrees Institution / Department, City & Country? Email Salutation, full name and degrees Institution / Department, City & Country? Email Please include above the details of the Primary Investigator of this study. List of Co-Investigators / Collaborators (multiple possible): Salutation, full name and degrees Institution / Department, City & Country? Email Salutation, full name and degrees Institution / Department, City & Country? Email Add more Study Group Members more Study Group Members You may add additional collaborators (max 100). For every collaborator, we will create an account with ISLSsg.org and they will be able to view and edit your study protocol. Study Details Study Details: Study Title? Indicate the study’s design with a commonly used term in the title or the abstract Summary? Provide here an informative and balanced summary of what will be done and how. Introduction Introduction Background/rationale? Explain the scientific background and rationale for the investigation to be conducted. Consider reporting on what is known, what is not known? Objectives? State specific objectives, including any prespecified hypotheses. Methods Methods Study design? Present key elements of study design Setting? Describe the setting, locations, and relevant dates, including periods of recruitment, exposure, follow-up, and data collection. Include center eligibility criteria. Participants? Give the eligibility criteria, and the sources and methods of selection of participants. Describe methods of follow-up. Variables? Clearly define all outcomes, exposures, predictors, potential confounders, and effect modifiers. Give diagnostic criteria, if applicable. Below, you will have the option to upload your excel file of all the list of variables associated with your study. List of variables / case report form upload List of Variables / Case Report Form Upload (optional) Please optionally upload below your list of variables preferably in excel format or the Case Report Form (CRF) in word or PDF format. By submitting your list of variables or CRF with your protocol, we will create and electronic CRF for you and all your collaborators to help with a more easy, secure, and complete data collection. Please include the variable names, allowed values, and which ones should be mandatory or not to complete the submission of each case. Upload your Case Report Form (optional)? One file only.512 MB limit.Allowed types: xls, xlsx, doc, docx, txt, rtf, pdf, odt, odp, ods. Data sources/measurement (optional)? For each variable of interest, give sources of data and details of methods of assessment (measurement) Bias (optional)? Describe any efforts to address potential sources of bias Study size? Explain how the study size will be arrived at. Quantitative variables (optional)? Explain how quantitative variables will be handled in the analyses. If applicable, describe which groupings will be chosen and why. Statistical methods? Describe all statistical methods, including those to control for confounding. Describe any methods to examine subgroups and interactions. Explain how missing data will be addressed. If applicable, explain how loss to follow-up will be addressed. Describe any sensitivity analyses if applicable. Discussion (optional) Discussion Message to the Scientific Committee of ISLS? Please provide the Scientific Committee with a short cover letter regarding your study and protocol submission.
