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{"sheet":"RMB Score Calculator","index":0,"n_rows":30,"n_cols":10,"rows_kept":30,"cut":false,"hidden":false,"merged":[[19,1,21,1],[22,1,23,1],[0,2,0,3],[0,0,0,1],[2,1,4,1],[5,1,11,1],[12,1,14,1],[15,1,18,1]]}
["Study title / identifier:",null,null,null,"Risk Category, according to ClinO:",null,"Filled out by:",null,"Date:"]
["N°","CATEGORY","RISK FACTOR (RF)","DESCRIPTION (of RF)","APPLICABLE?","IMPACT?","OCCURRENCE?","DETECTABILITY?","RISK SCORE","Comments / Rationale for RF"]
[1,"I. Subject","Vulnerable population","These subjects may include children or teenagers, healthy volunteers, students, pregnant women, geriatric subjects (over 80 years), those with cognitive or psychological disorders, immigrants, prisoners, etc.",null,null,null,null,{"$f":"IF(ISBLANK(F3:H3)=FALSE,E3*F3*G3*H3,E3)","v":0}]
[2,null,"Emergency situation","Consider if problems may occur with: \n• informed consent\n• assessment of eligibility criteria\n• immediate trial-related processes (such as diagnosis and therapy).\n\"Emergency\" is defined as necessity of immediate start of therapy (<12h), irrespective of the severity of the disorder.",null,null,null,null,{"$f":"IF(ISBLANK(F4:H4)=FALSE,E4*F4*G4*H4,E4)","v":0}]
[3,null,"Complexity of consent process","Consider if there are multiple informed consent processes (such as pre-screening or sub-studies).",null,null,null,null,0]
[4,"II. Design","Complexity of eligibility criteria","Consider number of criteria, ability to verify them, critical criteria (safety-relevant, relevant for the effectiveness of the therapy, relevant for the validity of the results), population stratification, documentation required for diagnosis, central vs. local laboratory, timelines of assessment, special tests / assessments for eligibility evaluation not routinely performed, etc.",null,null,null,null,0]
[5,null,"Complexity of design","Consider number of arms, adaptive design, randomisation, number of visits, dose, complicated or unusual procedures, study duration, strict timing for certain procedures, number of sites or centres, etc. Is it likely that the subject / investigator will not adhere to the treatment schedule?",null,null,null,null,0]
[6,null,"Complexity of primary endpoint (or important secondary endpoints)","Consider the robustness of the endpoint (objective / subjective, soft), if its assessment is complex or not standard (e.g. composite endpoint), and if special requirements are needed for its assessment.",null,null,null,null,0]
[7,null,"Bias impacting the primary endpoint (or important secondary endpoints)","Consider if there are any sources of bias or variance with regard to the endpoints. This can happen, for instance, if the trial is not randomised or is open label.",null,null,null,null,0]
[8,null,"Additional treatment for concomitant diseases / symptoms","Consider if the study population is likely to receive additional treatment for concomitant diseases (with input from a medical doctor required), and if this could affect the (efficacy) endpoints.",null,null,null,null,0]
[9,null,"Complexity of procedures","Consider unusual procedures.",null,null,null,null,0]
[10,null,"Withdrawals / drop-outs","Is there an increased risk of withdrawal or drop-out? E.g. might subjects withdraw from therapy or follow-up, as a result of very positive (or negative) therapeutic effects? Consider the possibility of non-compliance or withdrawal of consent. How is this taken into account in the trial design?\nIn trials focusing on efficacy differences, drop-outs could bias the results. Consider subject compliance in case of self treatment administration.",null,null,null,null,0]
[11,"III. Safety","Serious drug reaction / device effect","Consider if the trial therapeutic intervention is known to have any serious drug reaction / device effect? Have any events of special interest been identified? Consider any protocol-specific reporting requirements for SAE. ",null,null,null,null,0]
[12,null,"Interactions","Consider if there is a lack of previous experience on combination of trial therapeutic intervention being studied and other intervention / medications / devices. \nPay particular attention to any basic or background therapies, prescribed, recommended or allowed by the protocol, and to the timescale of potential interactions (see www.epocrates.com). ",null,null,null,null,0]
[13,null,"Subject population's condition","Consider if the subject population's condition is critically severe: potential for SAEs / subject risk, or complexity of disease state. Consider high WHO/ECOG scores (in oncological subjects). ",null,null,null,null,0]
[14,"IV. Intervention (IMP, IMD, surgery, etc.)","Actual knowledge","Consider if there is only very limited knowledge about at least one of the trial therapeutic interventions: experience of the sites, special logistic requirements, product stability and expiration dates, likelihood of serious drug reaction / device effect, relative to standard medical care.",null,null,null,null,0]
[15,null,"Administration","Consider if IMP administration or IMD utilisation is unusual, complex, etc.",null,null,null,null,0]
[16,null,"Logistics","Are there any essential / unusual storage, preparation, or destruction requirements for the IMP / IMD? It is necessary to analyse whether non-compliance with the storage requirements will actually increase the risk?\nAre there other trials using the same IMP / IMD (and, if so, evaluate the  risk of confusion)?",null,null,null,null,0]
[17,null,"Accidental or deliberate unblinding","E.g. by obtaining laboratory values from a local laboratory, physical differences between placebo and verum, adverse events, unblinding of a subject for treatment decision after trial treatment, etc.",null,null,null,null,0]
[18,"V. Management","Sites","Are there enough staff? Qualified staff?\nConsider if the site / PI is aware of their responsibilities (coordination / clarification of all issues / matters between the PI’s unit and other units at their hospital, e.g. radiology department, laboratory, etc.)\nThe overall participation is evaluated here (0−20% of all sites evaluated as problematic = low occurrence; 21−40% of all sites evaluated as problematic = medium occurrence; 41−100% of all sites evaluated as problematic = high occurrence). ",null,null,null,null,0]
[19,null,"Technical requirements","Consider if there are any technical requirements for the trial sites, e.g. access to diagnostic equipment, emergency equipment, unusual assessments to be done locally, new assessment tools, any essential processing, transport and / or storage requirements for material samples (e.g biological samples, biobanking which would require a fridge, freezer, a -80°C freezer, centrifuges, etc.)\nConsider to what extent the incorrect handling of samples may be critical. ",null,null,null,null,0]
[20,null,"Staff requirements","Consider if there are any essential personnel requirements for the trial sites, e.g. trial-specific knowledge or training certificates, training requirements for assessment of the primary endpoint, specialised laboratory staff.",null,null,null,null,0]
[21,"VI. Data","Volume / complexity","Consider the volume and complexity of data to be collected and if the source data is well identified.",null,null,null,null,0]
[22,null,"CRF quality","Consider eCRF vs. pCRF, design, software used (such as automatic checks, rules, or Monitor's role). ",null,null,null,null,0]
[23,"VII. Other","Any other risk","Consider any additional risks not yet taken into account. The risks should always be balanced against the risks associated with standard medical care for the indications in question.",null,null,null,null,0]
[null,null,null,null,null,null,null,"No.  low  RF (1-3)",{"$f":"COUNTIF(I3:I25,\">0\")-COUNTIF(I3:I25,\">3\")","v":0}]
[null,null,null,null,null,null,null,"No. medium RF (4-9)",{"$f":"COUNTIF(I3:I25,\">=4\")-COUNTIF(I3:I25,\">9\")","v":0}]
[null,null,null,null,"A",null,null,"No.  high RF (10-27)",{"$f":"COUNTIF(I3:I25,\">=10\")","v":0}]
[null,null,null,null,"B",null,null,"Recommended monitoring strategy:",{"$f":"IF(ISBLANK(F1),\"Select ClinO risk category in F1 cell\",IF(OR(AND(F1=\"A\",AND(I28<2,I27<13)),AND(F1=\"B\",AND(I28<1,I27<6))),\"low-risk\",IF(OR(AND(F1=\"C\",OR(I28>0,I27>5)),AND(F1=\"B\",OR(I28>1,I27>12))),\"high-risk\",\"medium-risk\")))","v":"Select ClinO risk category in F1 cell"}]
[null,null,null,null,"C"]

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