SOP-503
Pregnancy Reporting in Clinical Trials
- Number
- SOP-503
- Category
- Safety
- Edition
- Reference Edition 1.3
- Approx. pages
- 4
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On this page
1. Purpose
This SOP describes how [SITE NAME] counsels participants on pregnancy prevention, performs pregnancy testing, manages a participant who becomes pregnant, reports pregnancies of participants and of participants' partners to the sponsor, and follows each pregnancy to outcome.
2. Scope
This SOP applies to all trials at [SITE NAME] whose protocol includes contraception requirements, pregnancy testing, or pregnancy reporting. It covers pregnancies in female participants and, where the protocol requires, in female partners of male participants, from the start of the protocol-defined reporting window through the protocol-defined follow-up of the pregnancy and infant.
Out of scope: trials designed to enroll pregnant or lactating participants, which follow their protocol and IRB requirements for that population.
Follow the protocol, sponsor or IRB requirement where it is stricter than or more specific than this SOP. The protocol defines who is of childbearing potential, which contraceptive methods are acceptable, the test schedule and the reporting window.
3. Responsibilities
| Role | Responsibilities |
|---|---|
| Principal Investigator (PI) | Decides on IP interruption or discontinuation as the protocol requires, provides or arranges counseling and referral for prenatal care, reviews and signs pregnancy reports and outcome reports, and assesses any pregnancy complication or abnormal outcome as an AE or SAE. |
| Sub-Investigator (Sub-I) | Performs the PI's pregnancy-related assessments when delegated on F-302-01. |
| Clinical Research Coordinator (CRC) | Delivers and documents contraception counseling, performs or arranges pregnancy tests, reports pregnancies to the sponsor within the protocol timeline, obtains partner consent and authorization, follows the pregnancy to outcome, and maintains F-503-01. |
| Regulatory Coordinator | Confirms the IRB-approved pregnant partner consent and authorization documents are available before they are needed, and handles any IRB reporting under SOP-502. |
| Research Pharmacist or IP Manager | Withholds or retrieves IP on the PI's instruction and documents it (SOP-304). |
| Quality Lead | Includes pregnancy testing and counseling documentation in QC reviews (SOP-700). |
4. Definitions
| Term | Definition |
|---|---|
| Participant of childbearing potential | A participant who could become pregnant, as defined in the protocol (typically someone who is fertile after menarche and until becoming postmenopausal, unless permanently sterile). |
| Pregnancy reporting window | The period defined in the protocol during which pregnancies must be reported, usually from first dose (or consent) until a set time after the last dose of IP. |
| Partner pregnancy | A pregnancy in the female partner of a male participant, where the partner is not a trial participant. |
| Pregnant partner consent and authorization | An IRB-approved consent form and HIPAA authorization that the pregnant partner signs to permit the site to collect and report information about the pregnancy and its outcome. |
| Pregnancy outcome | The end result of the pregnancy: live birth (with infant status), spontaneous abortion, elective or therapeutic termination, ectopic pregnancy, stillbirth, or other outcome as the protocol lists. |
| Serious Adverse Event (SAE) | As defined in SOP-501. A congenital anomaly or birth defect is an SAE criterion. |
5. Procedure
5.1 Study start-up
5.1.1
Before activation, the Lead CRC records on the study page of F-503-01:
- the protocol definition of childbearing potential and any required documentation (for example, menopause confirmation by FSH, or surgical sterility records)
- acceptable contraceptive methods and their required duration for participants and partners
- the pregnancy test schedule and test type (serum or urine) and who performs it
- the pregnancy reporting window and reporting timeline (set by the protocol; often within 24 hours of awareness)
- the sponsor's pregnancy report form and outcome form and how they are submitted
- the required duration of pregnancy and infant follow-up
- whether partner pregnancies are reported, and the IRB-approved partner consent and authorization documents
5.1.2
Urine pregnancy tests performed at the site are waived tests and need at least a CLIA Certificate of Waiver covering the location where they are done (SOP-312). Staff follow the manufacturer's instructions. The CRC records kit lot and expiry where the sponsor requires it.
5.2 Contraception counseling
5.2.1
At consent, the CRC or investigator explains the protocol's contraception requirements to each participant of childbearing potential and to each male participant whose protocol has partner requirements, using the IRB-approved consent language.
5.2.2
Counseling covers the acceptable methods, how long contraception must continue after the last dose, what to do if a method fails or a period is missed, and the need to call the site immediately if a pregnancy is suspected.
5.2.3
The CRC documents the counseling and the method chosen in the source at consent, and repeats and documents counseling at the visits the protocol specifies, or at least [DEFAULT: at each dosing visit].
5.2.4
An investigator confirms childbearing status and contraceptive method as part of eligibility (SOP-303). A participant who does not meet the requirements is not enrolled.
5.3 Pregnancy testing
5.3.1
The CRC performs or arranges pregnancy tests at the times the protocol specifies. Results required before dosing must be available and reviewed by an investigator before IP is given.
5.3.2
A positive or equivocal result before dosing: the IP is not given. The CRC informs an investigator immediately. Where the protocol allows, a confirmatory serum test is ordered.
5.3.3
Test results are recorded in the source with date, time where needed, test type and result, and signed by the person performing or reviewing the test.
5.4 Participant pregnancy during the trial
5.4.1
Any staff member who learns that a participant is or may be pregnant informs the CRC and an investigator the same day. The awareness date is the date any member of the research staff first received the information.
5.4.2
The investigator decides on IP action as the protocol requires. Most protocols require immediate permanent discontinuation of IP; some allow continuation after a risk discussion. The Research Pharmacist or IP Manager withholds or retrieves IP as instructed and documents it (SOP-304).
5.4.3
The investigator discusses with the participant what is known about the IP's risks in pregnancy, using the IB and sponsor information, and recommends that the participant start or continue prenatal care. With the participant's agreement, the investigator informs the participant's obstetric provider of the trial and the IP exposure.
5.4.4
Emergency unblinding to manage the pregnancy follows SOP-305. The investigator unblinds only if knowing the treatment would change the participant's care.
5.4.5
Whether the participant continues in the trial for follow-up assessments, off IP, follows the protocol and the participant's choice (SOP-309).
5.5 Partner pregnancy
5.5.1
When a male participant reports that his partner is pregnant during the reporting window, the CRC records the report and the awareness date and informs an investigator.
5.5.2
The partner is not a trial participant. The site does not collect identifiable information about the partner's pregnancy or contact the partner's providers until the partner has signed the IRB-approved pregnant partner consent and HIPAA authorization.
5.5.3
Further details about the partner's pregnancy are collected only after the partner signs.
5.5.4
The male participant asks the partner whether she is willing to be contacted, or gives her the site's contact details. The CRC does not contact the partner directly without her agreement, communicated through the participant, unless the IRB-approved process says otherwise.
5.5.5
If the partner declines, the CRC records the decline and reports no further information about the pregnancy. The participant's continued participation is not affected.
5.6 Reporting to the sponsor
5.6.1
The CRC completes the sponsor's pregnancy report within the protocol timeline from the awareness date, including estimated date of conception or last menstrual period, estimated due date, IP exposure details and relevant medical history.
5.6.2
An investigator reviews and signs the report. The CRC submits it, records the submission on F-503-01 and files the report and acknowledgment.
5.6.3
Pregnancy itself is not an AE or SAE unless the protocol says so. Pregnancy complications (for example, hyperemesis requiring admission, pre-eclampsia, ectopic pregnancy) and abnormal outcomes are assessed under SOP-500 and, where serious, reported under SOP-501.
5.6.4
The PI assesses whether the pregnancy, or information about it, must be reported to the IRB under SOP-502 (for example, a pregnancy that occurred because the consent form did not describe a risk, or an outcome suggesting a new risk).
5.7 Follow-up to outcome
5.7.1
The CRC contacts the participant or consenting partner at the intervals the protocol specifies, or at least [DEFAULT: once each trimester and at the estimated due date], and records each contact on F-503-01 and in the source (SOP-309 contact rules apply).
5.7.2
The CRC requests obstetric and delivery records under the participant's or partner's authorization and redacts identifiers before sending to the sponsor (SOP-501 section 5.5).
5.7.3
The CRC submits the pregnancy outcome report within the protocol timeline after learning of the outcome. Infant follow-up continues for the period the protocol requires, using the consent and authorization that covers the infant, where the protocol requires it.
5.7.4
Outcomes that meet SAE criteria (for example, congenital anomaly or birth defect, stillbirth, spontaneous abortion where the protocol classifies it as serious, neonatal death) are reported as SAEs under SOP-501 within the SAE timeline.
5.7.5
If the participant or partner cannot be reached after the attempts required by the protocol, the CRC records the pregnancy as lost to follow-up on F-503-01 and informs the sponsor.
5.7.6
Pregnancies are followed to outcome even if the participant has completed or left the trial, unless the participant or partner withdraws agreement.
6. Related Forms and SOPs
- F-503-01 Pregnancy Report Tracker
- F-302-01 Delegation of Authority Log
- F-309-01 Participant Contact and Retention Log
- SOP-301 Informed Consent Process and Documentation
- SOP-303 Screening, Eligibility Verification and Enrollment
- SOP-304 Investigational Product Management
- SOP-305 Randomization, Blinding and Emergency Unblinding
- SOP-309 Participant Retention, Withdrawal and Lost to Follow-Up
- SOP-312 Equipment Calibration and Maintenance; Local Laboratory Requirements
- SOP-400 Participant Privacy and HIPAA in Research
- SOP-500 Adverse Event Identification, Assessment and Recording
- SOP-501 Serious Adverse Event and Expedited Safety Reporting
- SOP-502 Unanticipated Problems and Reportable New Information
- Appendix B Central and Site Responsibility Matrix (Model N only)
7. References
| Reference | Title |
|---|---|
| 21 CFR 50.25 | Elements of Informed Consent |
| 21 CFR 312.64(b) | Investigator Reports: Safety Reports |
| 45 CFR 164.508 | Uses and Disclosures for Which an Authorization Is Required |
| 42 CFR 493 | Laboratory Requirements (CLIA) |
| ICH E6(R3) Annex 1, 2.7 | Participant Medical Care and Safety Reporting |
| ICH E6(R3) Annex 1, 2.8 | Informed Consent of Trial Participants |
| ICH E2A | Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
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