Table of Content

Electronic CRF COMPLETION GUIDELINES 0

1. General rules for electronic Case Report Form completion (9)

1.1 How to enroll a new subject .....如何加入一个新受试者.. (9)

1.2 Entering and editing data ..........数据的输入和编辑 (9)

1.3 MedDRA specific instructions 数字式记录的具体说明11

1.4 How to enter data in a repeating form ......在重复表单中如何输入数据. (14)

1.5 Delete a record in a repeating form .............删除数据.. (14)

1.6 Screen Failure..................筛选失败 (19)

1.7 Pre-screen Failure ......预检失败.. (19)

2. Form specific completion guideline ....具体完成索引.. (19)

2.1 Screening Visit ..........筛选访问. (19)

2.1.1 pgx (pharmacogenetics) 药理学 (19)

2.1.2 dem (Demographics) .....人口统计学.. (20)

2.1.3 diag (Diagnosis of Disease)....疾病诊断.. (20)

2.1.4 ddmd (Documentation of Distant Metastatic Disease) ......远处转移病灶文件. (21)

2.1.5 mhxdt (Medical History Detail) ..病历细节 (22)

2.1.6 sphx (History of surgeries/ procedures unrelated to study condition) .手术/操作史与研究无关23

2.1.7 sphxdt (History of surgeries/ procedures details unrelated to study condition) . 手术史/操作细节与研究无关. 23

2.1.8 prtscrc (Previous Therapy and Surgery for CRC) 之前的治疗和手术 (24)

2.1.9 prtscrcdt (Previous Therapy and Surgery for CRC details) . 之前的治疗和手术.. 24

2.1.10 hx (History of Medication / Therapies unrelated to Study Condition)用药史和治疗史与研究无关25

2.1.11 hxdt (History of Medication / Therapies Details unrelated to Study Condition) ......... 用药史和治疗史细节与研究无关25

2.1.12 prether (Prior Anti-Cancer Drug Therapies) ..之前抗癌药物的治疗 (25)

2.1.13 pretherdt (Prior Anti-Cancer Drug Therapies Detail) . 之前抗癌药物的治疗细节 (26)

2.1.14 ecog (ECOG Performance Status) .......体力状态 (26)

Electronic CRF COMPLETION GUIDELINES EMR62 202-057

2.1.15 pe (Physical Examination) ..身体检查 (26)

2.1.16 vs (Vital Signs) ....生命体征 (26)

2.1.17 ecg (Electrocardiogram) ..心电图 (27)

2.1.18 muga (MUGA/ UCG (Ultrasonic Cardiogram)) ....超声心动图. (27)

2.1.19 cxr (Chest X-ray) ...胸片. (27)

2.1.20 haem (Haematology) / chem (Blood Chemistry) / elec (Electrolytes)血红素/生化/电解质28

2.1.21 qol ([Quality of life] Questionnaire) .生活质量问卷 (28)

2.1.22 eortc (EORTC QLD - C30) (29)

2.1.23 entry (Study Entry) ....进入研究 (29)

2.1.24 preg (Pregnancy Test) .怀孕测试 (31)

2.1.25 pgx1 (Pharmacogenetics) ..药理学 (32)

2.1.26 pksc (PK Schedule) ....药代阶段 (32)

2.1.27 rand (Randomization) .....随机 (33)

2.1.28 haca (HACA) (33)

2.2 Cum (33)

2.2.1 aecmcp (AE/CM/CP) (34)

2.2.2 aedt (Adverse Events Details) ....不良事件细节. (34)

2.2.3 cmeddt (Concomitant Medication Detail) ..合并用药细节 (40)

2.2.4 cprodt (Concomitant Procedures Detail) ..伴随程序细节 (42)

2.2.5 death ......死亡 (43)

2.2.6 LES (Tumor Assessment) .........肿瘤评估 (43)

2.2.7 tmtl (Tumor Measurement (according to RECIST) - Target Lesions) .肿瘤测量（根据）目标病灶 (43)

2.2.8 sold (Tumor Measurement (according to RECIST) – Sum of Longest Diameters) ..总和最长直径 (46)

2.2.9 tmntl (Tumor Measurement (according to RECIST) – Non-Target Lesions) 非靶病灶48 2.2.10 tmnl (Tumor Measurement (According to RECIST) – New Lesions) .新病灶 (51)

2.2.11 eor (Assessment of Disease Based on Imaging (according to RECIST)) 根据影像的疾病评估.. 53

2.3 CXD1, CXD8 (54)

2.3.1 haem (Haematology)/ elec (Electrolytes) 血色素/生化 (54)

2.3.2 vs (Vital Signs) ..生命体征 (54)

2.3.3 ecg (Electrocardiogram) ..心电图 (54)

2.3.4 pmed (Premedication)/ pmeddt(Premedications Details) ..前期用药/细节 (54)

2.3.5 pk (PK Schedule 1/ PK Schedule 2) .PK附表1/2 (55)

2.3.6 ctixiad (Administration of Cetuximab) .cetuximab管理 (55)

2.3.7 folfoxdt (FOLFOX Administration Details) ..管理细节 (56)

2.3.8 biom (Biomarkers) ...生物标志物. (56)

2.4 EV .....电子伏特. (57)

2.4.1 dov ......硫酸 (57)

2.4.2 vs (Vital Signs) ..........生命体征.. (57)

2.4.3 pe (Physical Examination) ..身体检查 (58)

2.4.4 ecog (ECOG Performance Status) (58)

2.4.5 ecg (Electrocardiogram) ........心电图. (58)

2.4.6 cxr (Chest X-Ray) ........胸片. (58)

2.4.7 chem (Blood Chemistry) ......生化 (58)

2.4.8 elec (Electrolytes ) ..............电解质. (58)

2.4.9 qol / eortc (qol ([Quality of life] Questionnaire) / eortc (EORTC QLD - C30)) ....生活质量问卷 (59)

2.4.10 aspd (Assessment of progression of disease (according to RECIST) ...疾病进展的评估.. 59 2.4.11 muga (MUGA/ UCG (Ultrasonic Cardiogram)) ..超声心动图. (59)

2.4.12 heam (Haematology) ..血色素 (59)

2.4.13 biom (Biomarkers) ....生物标志物 (59)

2.5 PSE (Post Surgery Evaluation) ..手术后评估 (59)

2.5.1 surg (Surgery).....手术. (59)

2.6 addvis (Additional visit) ..附加访视 (60)

2.6.1 dov (Date of Visit) ..........访视的时间 (60)

2.6.2 vtype (Visit Type) .........访视的形式.. (60)

2.7 EOT (End of Trial) .........试验结束. (61)

2.7.1 tterm (Treatment Termination) ....治疗结束 (61)

2.7.2 pgxw (Pharmacogenetics withdrawal) ...药理学退出.. (62)

2.8 FU (Follow-up) ....后续. (62)

2.8.1 fups (Follow up status) ...后续状态 (62)

2.8.2 futrt (Anti-cancer treatment after discontinuation) / futrtdt (Anti-cancer Treatment after Discontinuation detail) ...抗癌治疗，停药后抗癌治疗的细节.. (62)

2.8 Unsc (Unscheduled) ..........不定期.. (63)

2.9 sterm (Study Termination ) ..研究结束 (63)

3. Electronic CRF completion guidelines Approval......许可. (64)

4. Reference .....参考 (64)