Online training class for Clinical R programming batch starts on Monday, 30Jun2025.
Click here for details.
Online training class for Clinical R programming batch starts on Monday, 30Jun2025.
Click here for details.
| Example | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|
| IG33_TE_TE_001 | EX1 | TE | SCRN | Screen | Informed consent | 1 week after start of Element | P7D |
| IG33_TE_TE_001 | EX1 | TE | RI | Run-In | Eligibility confirmed | 2 weeks after start of Element | P14D |
| IG33_TE_TE_001 | EX1 | TE | P | Placebo | First dose of study drug, where drug is placebo | 2 weeks after start of Element | P14D |
| IG33_TE_TE_001 | EX1 | TE | A | Drug A | First dose of study drug, where drug is Drug A | 2 weeks after start of Element | P14D |
| IG33_TE_TE_001 | EX1 | TE | B | Drug B | First dose of study drug, where drug is Drug B | 2 weeks after start of Element | P14D |
| Example | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|
| IG33_TE_TE_002 | EX2 | TE | SCRN | Screen | Informed consent | 2 weeks after start of Element | P14D |
| IG33_TE_TE_002 | EX2 | TE | P | Placebo | First dose of a treatment Epoch, where dose is placebo | 2 weeks after start of Element | P14D |
| IG33_TE_TE_002 | EX2 | TE | 5 | 5 mg | First dose of a treatment Epoch, where dose is 5 mg drug | 2 weeks after start of Element | P14D |
| IG33_TE_TE_002 | EX2 | TE | 10 | 10 mg | First dose of a treatment Epoch, where dose is 10 mg drug | 2 weeks after start of Element | P14D |
| IG33_TE_TE_002 | EX2 | TE | REST | Rest | 48 hrs after last dose of preceding treatment Epoch | 1 week after start of Element | P7D |
| IG33_TE_TE_002 | EX2 | TE | FU | Follow-up | 48 hrs after last dose of third treatment Epoch | 3 weeks after start of Element | P21D |
| Example | STUDYID | DOMAIN | ETCD | ELEMENT | TESTRL | TEENRL | TEDUR |
|---|---|---|---|---|---|---|---|
| IG33_TE_TE_003 | EX4 | TE | SCRN | Screen | Informed Consent | Screening assessments are complete, up to 2 weeks after start of Element | |
| IG33_TE_TE_003 | EX4 | TE | A | Trt A | First dose of treatment Element, where drug is Treatment A | 5 days after start of Element | P5D |
| IG33_TE_TE_003 | EX4 | TE | B | Trt B | First dose of treatment Element, where drug is Treatment B | 5 days after start of Element | P5D |
| IG33_TE_TE_003 | EX4 | TE | REST | Rest | Last dose of previous treatment cycle + 24 hrs | At least 16 days after start of Element and WBC recovered | |
| IG33_TE_TE_003 | EX4 | TE | FU | Follow-up | Decision not to treat further | 4 weeks | P28D |