•Allow time necessary for participant or participant's legally acceptable representative to inquire about the details of the study. •Obtain an informed consent signed and personally dated by the participant or the participant's legally acceptable representative and by the pe rson who conducted the informed consent discussion. •Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent form and any other information to be provided to th e subjects/participants, prior to the beginning of the study, and after any revisions are completed for new information. If informed consent is initially given by a participant’s legally acceptable representative or legal guardian, and the participant subsequently becomes capable of making and communicating his or her informed consent during the study, consent must additionally be obtained from the participant. Revise the informed consent whenever impor tant new information becomes available that is relevant to the participant's consent. The inve stigator, or a person designated by the investigator, should fully inform the participant or the part icipant's legally acceptable representative or legal guardian, of all pertinent aspects of the study and of any new information relevant to the participant's willingness to continue participation in the st udy. This commun ication should be documented. The confidentiality of records that could identify subjects/participants must be protected, respecting the privacy and confidentiality rules applicable to regulatory requirements, the subjects'/participants’ signed ICF and, in the US, the subjects’/participants’ signed HIPAA Authorization. The consent form must also include a statement that BMS and regulatory authorities have direct access to par ticipant records. The rights, safety, and well-being of the study subjects/participants are the most important considerations and should prevail over interests of science and society. SOURCE DOCUMENTS The Investigator is responsible for ensuring that the source data are accurate, legible, contemporaneous, original and attributable, whether the data are hand-written on paper or entered electronically. If source data are created (first entered), modi fied, maintained, archived, retrieved, or transmitted electronically via computer ized systems (and/or any other kind of electronic devices) as part of regulated clinical trial activities, such systems must be compliant with all applicable laws and regulations governing use of e lectronic records and/ or electronic signatures. Such systems may include, but are not limited to, electronic medical/health records (EMRs/EHRs), Revised Protocol No.: 04 Date: 31-May-2019 168 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS adverse event tracking/reporting, protocol re quired assessments, and/or drug accountability records). When paper records from such systems are used in place of electronic format to perform regulated activities, such paper records should be certified copies. A certified copy consists of a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and i nformation as the original. STUDY TREATMENT RECORDS Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate study treatment integrity and traceability from receipt, preparation, administration, and through destruction or return. Records must be made available for review at the request of BMS/designee or a Health Authority. If Then Supplied by BMS (or its vendors): Records or logs must comply with applicable regulations and guidelines and should include: •amount received and placed in storage area •amount currently in storage area •label identification number or b atch number •amount dispensed to and returned by each participant, including unique participant identifiers •amount transferred to another area/site for dispensing or storage •nonstudy disposition (e.g., lost, wasted) •amount destroyed at study site, if applicable •amount returned to BMS •retain samples for bioavailability/bioequivalence/biocomparability, if applicable •dates and initials of person responsible for Investigational Product dispensing/accountability, as per the Delegation of Authority Form. Sourced by site, and not supplied by BMS or its vendors (examples include IP sourced from the sites stock or commercial supply, or a sp ecialty pharmacy)The investigator or desi gnee accepts re sponsibility for documenting traceability and study drug integrity in accordance with requirements applicable under law and the SOPs/standards of the sourcing pharmacy. These records should include: Revised Protocol No.: 04 Date: 31-May-2019 169 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS If Then •label identification number or b atch number •amount dispensed to and returned by each participant, including unique participantidentifiers •dates and initials of person responsible for Investigational Product dispensing/accountability, as per the Delegation of Authority Form. BMS or designee will provide forms to facilitate inventory control if the i nvestigational site does not have an established system that meets these requirements. CASE REPORT FORMS An investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other d ata pertinent to the investig ation on each i ndividual treated or entered as a control in the investigation. Data that are derived from source documents and reported on the CRF must be consistent with the source documents or the discrepancies must be explained. Additional clinical information may be coll ected and analyzed in an effort to enhance understanding of product safety. CRFs may be reque sted for AEs and/or laboratory abnormalities that are reported or identified during the course of the study. For sites using the Sponsor or designee elect ronic data capture tool, electronic CRFs w ill be prepared for all data collection fields except for fields specific to SAEs and pregnancy, which will be reported on the electronic SAE form and Pregnancy Surveillance form, respectively. If electronic SAE form is not av ailable, a paper SAE form can be used. Spaces may be left blank only in those circumstances permitted by study-s pecific CRF completion guidelines provide d by Sponsor or designee. The confidentiality of records that could identify subjects/participants must be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). The investigator will maintain a signature sheet to document signatures and initials of all persons authorized to make entries and/or corrections on CRFs. The completed CRF, SAE/pregnancy CRFs, must be promptly reviewed, signed, and dated by the investigator or qualified physician who is a subinve stigator and who is delegated this task on the Delegation of Authority Form. Subinvestigators in Japan may not be delegated the CRF approval task For elect ronic CRFs, review and approval/signature is completed el ectronically through the BMS electronic data capture tool. The investigator must r etain a copy of the CRFs including records of the changes and corrections. Each individual electronically signing el ectronic CRFs must meet S ponsor or designee training requirements and must only access the BMS elect ronic data capture tool using the unique user Revised Protocol No.: 04 Date: 31-May-2019 170 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS account provided by Sponsor or designee. User accounts are not to be shared or reassigned to other individuals MONITORING Sponsor or designee representatives will review data centrally to identify potential issues to determine a schedule of on-site visits f or targeted review of study records. Representatives of BMS must be allowed to visit all study site locations periodically to assess the data quality and study integrity. On site they will review study records and directly compare them with source documents, discuss the conduct of the study with the investigator, and verify that the facilities remain acceptable. In addition, the study may be evaluated by Sponsor or designee internal auditors and government inspectors who must be allowed access to CRFs, source documents, other study files, and study facilities. BMS audit reports will be kept confidential. The investigator must notify BMS promptly of any inspections scheduled by regu latory aut horities, and promptly forward copies of inspection reports to Sponsor or designee. RECORDS RETENTION The investigator (or head of the study site in Japan) must retain all st udy records and source documents for the maximum period required by applicable regulations and guidelines, or institution procedures, or for the period specified by BMS or designee, whichever is longer. The investigator (or head of the study site in Japan) must contact BMS prior to destroying any records associated with the study. BMS or designee will notify the investigator (or head of the study site in Japan) when the study records are no longer needed. If the investigator withdraws from the study (e g, relocation, retirement), the records sh all be transferred to a mutually agreed upon designee (e g, another investigator, study site, IRB). Notice of such transfer will be given in writing to BMS or designee. RETURN OF STUDY TREATMENT For this study, study treatments (those supplied by BMS, a vendor or sourced by the investigator) such as partially used study treatment container s, vials and syringes may be destroyed on site. If.. Then Study treatments supplied by BMS (including its vendorsAny unused study treatments s upplied by BMS can only be destroyed after being inspected and reconciled by the responsible Study Monitor unless study treatments containers must be immediately destroyed as required for safety, or to meet local regulations (e.g., cytotoxics or biologics). Revised Protocol No.: 04 Date: 31-May-2019 171 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS If study treatments will be returned, the return will be arranged by the responsible Study Monitor. Study treatments sourced by site, not supplied by BMS (or its vendors) (examples include study treatments sourced from the sites stock or commercial supply, or a specialty pharmacy)It is the investigator’s or designee’s responsibility to dispose of all containers according to the institutional guidelines and procedures. It is the investigator’s or designee’s responsibility to arrange for disposal, provided that procedures for proper disposal have been established accord ing to applicable feder al, state, local, and institutional guidelines and procedures, and provided that appropriate records of disposal are kept. The following minimal standards must be met: •On-site disposal practices must not expose humans to risks from the drug. •On-site disposal practices and procedures are in agr eement with applicable laws and regulations, including any special requirements for controlled or hazardous substances. •Written procedures for on-site disposal are available and followed. The procedures must be filed with the site’s SOPs and a copy provide d to BMS upon request. •Records are maintained that allow for traceability of each container, including the date disposed of, quantity disposed, and identificati on of the person disposing the containers. The method of disposal, i.e., incinerator, licensed sanitary landfill, or licensed waste disposal vendor must be documented. •Accountability and disposal records are complete , up-to-date, and available for the Monitor to review throughout the clinical trial period. It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers. If conditions for destruction cannot be met the responsible Study Monitor will make arrangements for return of study treatments provided by BMS (or its vendors). Destruction of non- study treatments s ourced by the site, not supplied by BMS, is solely the responsibility of the investigator or designee. CLINICAL STUDY REPORT A Signatory Investigator must be selected to sign the clinical study report. For each CSR r elated to this protocol, the following criteria will be used to select the signatory investigator: •Participant recruitment (e.g., among the top quartile of enro llers) •Involvement in trial design •Other criteria (as determined by the study team) Revised Protocol No.: 04 Date: 31-May-2019 172 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS SCIENTIFIC PUBLICATIONS The data collected during this study are confident ial and proprietary to Sponsor or designee. Any publications or abstracts arising from this study must adhere to the publication requirements set forth in the clinical trial agreement (CTA) governing [Study site or Investigator] par ticipation in the study.