Amend guidance around ClinicalTrials.gov upload

[LisaHopcroft]

ClinicalTrials.gov submissions are more demanding in terms of information as this is manually reviewed. Add some guidance to the EudraCT/ClinicalTrials.gov template document to indicate that the user should think about the following (examples are provided from NAXIVA triage):

• Descriptions of scales or categories (e.g., Mayo classification, Clavien Dindo, surgical hierarchies of morbidity)
• Revise the outcome measures to only include information related to the assessment for which data are presented
• Report all primary and secondary endpoints
• Consider using an Outcome Measure Title that accurately indicates what was measured and is reported in the Outcome Measure data table (e.g., "Percentage of Participants with Changes in Control of IVC/Renal Vein", etc., as accurate and appropriate)
• Consider including additional information in the Measure Description that clarifies any methods and/or criteria used to assess the outcome (e.g., "control of IVC/renal vein")
• Use outcome-neutral language in Outcome Measure Titles, Descriptions, and Units of Measure (e.g., "change" instead of "reduction"), particularly where a negative number indicates an increase (for example). If the change is not calculated as the value at the later time point minus the value at the earlier time point, then please make calculation details explicit in the Measure Description to clarify the meaning of positive and negative values.
• Consider providing a brief but explicit summary of the criteria used for this Outcome Measure. For example, "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.