HPTN 035 SSP Section 6 - Microbicide Trials Network
|Sample Pregnancy Management Worksheet for HPTN 035 |
| |
|PARTICIPANT ID: |
|BACKGROUND INFORMATION |
| | |
|First day of last menstrual period | |
| | |
|Date of positive pregnancy test | |
| | | |
|Estimated week 24 and full term pregnancy dates |Week 24: |Full Term: |
| |Mark ( | |
|PREGNANCY MANAGEMENT INFORMATION |When Done |Initials/Date/Comments |
| | | | |
|1 |Pregnancy Report and History form completed and faxed to | | |
| |SCHARP | | |
| | | | |
|2 |Pharmacy informed of pregnancy | | |
| |(NA if participant in condom only group) | | |
| | | | |
|3 |Product supplies retrieved from participant and returned | | |
| |to pharmacy | | |
| |(NA if participant in condom only group) | | |
| | | | |
|4 |Product Hold/Discontinuation form completed (items 1-3) | | |
| |and faxed to SCHARP | | |
| |(NA if participant in condom only group) | | |
| | | | |
|5 |Pregnancy outcome and outcome date ascertained, based on: | | |
| |( medical records or other written documentation from a | | |
| |licensed non-study health care practitioner | | |
| |( participant self-report | | |
| |( negative pregnancy test performed by study staff | | |
| |( other (specify in comments) | | |
| |(medical records should be obtained whenever possible) | | |
| | | | |
|6a |Pregnancy Outcome form completed and faxed to SCHARP | | |
| | | | |
|6b |If applicable, AE Log form completed and faxed to SCHARP | | |
| | | | |
|6c |If applicable, EAE Report completed and faxed to DAIDS | | |
| |Safety Office | | |
| |(NA if participant in condom only group) | | |
|For participants in a gel group, continue with items 7-9. |
|For participants in the condom only group, items 7-9 are not applicable. Stop here. |
| |
| |
|7. The participant is eligible to resume gel use as of the date of her first negative pregnancy test performed post-pregnancy by study staff, |
|provided a pelvic exam is performed prior to resumption of gel use, and the exam identifies no findings that would contraindicate resumption of |
|gel use. Based on pregnancy tests and pelvic exams performed by study staff, enter the date when the participant is eligible to resume product |
|use here: |
| |
| |
| |
| |
| |
| |
|Date determined by (initials and date): _____________________ |
| |
|Date verified by (initials and date): _____________________ |
| |
| |
|Note: Contact the HPTN 035 Protocol Safety Review Team with any questions related to resumption of gel use. |
| | | | |
|8 |Pharmacy informed of participant eligibility to resume gel| | |
| |use | | |
| | | | |
|9 |Product Hold/Discontinuation form updated (item 4) and | | |
| |faxed to SCHARP | | |
| |
|Additional Comments (if any; initial and date all entries; continue on back if needed): |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related download
- visit ky chfs
- the official website of the state of indiana
- onestep hcg pregnancy test
- one step hcg urine pregnancy test strip 019
- urine pregnancy test mainline confirm hcg
- pregnancy test ati hcg ampcor
- hptn 035 ssp section 6 microbicide trials network
- agglutination pregnancy test
- bluegrass community hospital
- authorizad for local reproduction
Related searches
- indy time trials on tv
- dental implant trials open
- dental implants clinical trials 2019
- step up for writing section 6 narratives
- dental trials and studies
- american neurological association clinical trials course
- johns hopkins clinical trials cancer
- japanese trials after ww2
- japanese war crimes trials ww2
- nuremberg trials executions
- nazi trials after war
- wwii trials for nazi