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MTN-034 Clinical Flow Sheets

This comprehensive guide provides detailed protocols for managing Grades 1-4 adverse events (AEs) in clinical trials, including specific steps for product use management. It covers topics such as creatinine clearance, sexually transmitted infections, and vaginal ring use, with clear instructions for assessment and decision-making. Ensure seamless AE handling with this essential resource.

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MTN-034 Clinical Flow Sheets

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  1. MTN-034 Clinical Flow Sheets Version 1.0 12 July 2017

  2. Product Use Management: Grade 1 and Grade 2 Adverse Events AE addressed in protocol section 9.5? no CONTINUE product. yes Follow relevant protocol section Protocol Reference: Section 9.4

  3. START Product Use Management: Grade 3 Adverse Events AE addressed in protocol sections 9.5? Assess AE relationship to product not related no CONTINUE product. yes related Follow relevant protocol section HOLD product. Re-evaluate at least weekly for up to 2 weeks. RESUME product. If same grade 3 AE recurs, regardless of relationship to product, HOLD product and CONSULT PSRT. grade ≤2 within 2 weeks after initiating hold grade >2 through 2 weeks after initiating hold Consult PSRT Protocol Reference: Section 9.4

  4. Product Use Management: Grade 4 Adverse Events AE addressed in protocol section 9.5? HOLD product. CONSULT PSRT. no yes Follow relevant protocol section Protocol Reference: Section 9.4

  5. START Product Use Management for ORAL Study Product: Decreased Creatinine Clearance Assess creatinine clearance rate  60 mL/min CONTINUE product. < 60 mL/min HOLD product and consult the PSRT. Re-test within 1 week of receipt of result. Continue HOLD and CONSULT PSRT. • 60 mL/min on re-test No re-test within 1 week < 60 mL/min on re-test Continue HOLD and CONSULT PSRT. PERMANENTLY DISCONTINUE product. Protocol Reference: Section 9.5

  6. Product Use Management: Sexually Transmitted Infections and Reproductive Tract Infections CONTINUE product, unless permanent discontinuation guidelines apply. Consult the PSRT if a permanent discontinuation is deemed necessary and instituted by the IoR/designee. Vaginally applied medications should not be used. Whenever possible, oral or parenteral medications should be used instead. *Treat per WHO guidelines, using observed single dose regimens whenever possible. Protocol Reference: Section 9.5

  7. Product Use Management during VAGINAL RING use: Superficial epithelial disruption (abrasion/peeling) HOLD product and consult the PSRT. CONTINUE product. Perform naked eye exam. Yes Re-evaluate by speculum exam in 3-5 days. Is it worse? No CONTINUE product. Protocol Reference: Section 9.5

  8. Product Use Management during VAGINAL RING use : Deep epithelial disruption (ulceration) If confirmed by investigator, HOLD Product CONTINUEHOLD consult the PSRT. No No Yes Yes Re-evaluate by speculum exam in 2-3 days. Has it resolved? Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. CONTINUE product. If reoccurrence with no identified etiology, hold product and consult the PSRT regarding permanent discontinuation Protocol Reference: Section 9.5

  9. Product Use Management during VAGINAL RING use : Localized erythema or edema (area less than 50%) CONTINUE product. Perform naked eye exam. HOLD product and consult the PSRT. Symptomatic? Yes Re-evaluate by speculum exam in 3-5 days. Is it worse? No Asymptomatic? CONTINUE product. Re-evaluate at next scheduled visit Protocol Reference: Section 9.5

  10. Product Use Management during VAGINAL RING use : Generalized Erythema or Severe Edema (area more than 50%) HOLD Product and perform naked eye examination CONTINUEHOLD consult the PSRT. No No Yes Yes Re-evaluate by speculum exam in 2-3 days. Has it resolved? Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. CONTINUE product. If reoccurrence with no identified etiology, hold product and consult the PSRT regarding permanent discontinuation Protocol Reference: Section 9.5

  11. Product Use Management during VAGINAL RING use : Unexpected genital bleeding Follow guidance for deep epithelial disruption CONTINUE product and perform naked eye pelvic examination Due to deep epithelial disruption? yes Continue Product use no Protocol Reference: Section 9.5

  12. Product Use Management during VAGINAL RING use : Cervicitis (including inflammation and/or friability) HOLD Product and evaluate for GC/CT; provide treatment as indicated CONTINUEHOLD consult the PSRT. No Yes Re-evaluate by speculum exam in 3-5 days. Has it resolved? CONTINUE product. Protocol Reference: Section 9.5

  13. Product Use Management during VAGINAL RING use : Genital petechia(e)/ genital ecchymosis CONTINUE product and perform naked eye exam; treat per clinician discretion Protocol Reference: Section 9.5

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